S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

December 14, 2022 updated by: Southwest Oncology Group

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).

Secondary

To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory)
To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory)
To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory)
To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory)
To investigate whether daily duloxetine decreases analgesic use.
To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory)
To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory)
To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)
To explore the impact of treatment on serum inflammatory cytokine levels with 12 weeks of treatment at baseline and 12 weeks. (Exploratory)
To bank blood samples for future correlative analyses. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain score (4-6 vs 7-10), and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.
Arm II: Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

Patients complete the modified Brief Pain Inventory Short Form (BPI-SF) questionnaire at baseline and periodically during study treatment. Patients may also complete the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale, the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES), Global Rating of Change Scale, and the patient Health Questionnaire (PHQ-9).

Patients undergo blood sample collection at baseline and periodically during treatment for correlative studies, including biomarker and genetic studies.

After completion of study treatment, patients are followed up for 168 days.

Study Type

Interventional

Enrollment (Actual)

299

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Memorial Hospital
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - Fowler Family Center for Cancer Care
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Auburn, California, United States, 95602
    - Sutter Auburn Faith Hospital
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills - Peninsula Hospitals
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Davis, California, United States, 95616
    - Sutter Davis Hospital
  - Dublin, California, United States, 94568
    - Epic Care-Dublin
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Emeryville, California, United States, 94608
    - Epic Care Partners in Cancer Care
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Pasadena, California, United States, 91105
    - Huntington Memorial Hospital
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - Sacramento, California, United States, 95816
    - Sutter General Hospital
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Cruz, California, United States, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - Santa Rosa, California, United States, 95403
    - Sutter Pacific Medical Foundation
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Sunnyvale, California, United States, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vacaville, California, United States, 95687
    - Northbay Cancer Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Whittier, California, United States, 90602
    - Presbyterian Intercommunity Hospital
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80222
    - Colorado Cancer Research Program NCORP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80113
    - Comprehensive Cancer Care and Research Institute of Colorado LLC
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Farmington, Connecticut, United States, 06030
    - University of Connecticut
  - Greenwich, Connecticut, United States, 06830
    - Greenwich Hospital
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20002
    - Kaiser Permanente-Capitol Hill Medical Center
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Lake Worth, Florida, United States, 33461
    - Cancer Center of South Florida-Lake Worth
  - Lakeland, Florida, United States, 33805
    - The Watson Clinic
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital Orlando
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Hospital
- Georgia
  - Athens, Georgia, United States, 30607
    - University Cancer and Blood Center LLC
  - Augusta, Georgia, United States, 30912
    - Augusta University Medical Center
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Valdosta, Georgia, United States, 31602
    - South Georgia Medical Center/Pearlman Cancer Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Oncology Inc-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc-POB II
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Oncology Inc-Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Medical Center
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Berwyn, Illinois, United States, 60402
    - Mac Neal Hospital
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Elk Grove Village, Illinois, United States, 60007
    - AMITA Health Alexian Brothers Medical Center
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Evergreen Park, Illinois, United States, 60805
    - Little Company of Mary Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates Incorporated
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Radiation Oncology of Northern Illinois
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - River Forest, Illinois, United States, 60305
    - West Suburban Medical Center
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62702
    - Central Illinois Hematology Oncology Center
  - Swansea, Illinois, United States, 62226
    - Cancer Care Specialists of Illinois-Swansea
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Crown Point, Indiana, United States, 46307
    - Michiana Hematology Oncology PC-Crown Point
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Indianapolis, Indiana, United States, 46219
    - Community Hospital East
  - Indianapolis, Indiana, United States, 46256
    - Community Regional Cancer Care-North
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Merrillville, Indiana, United States, 46410
    - Premier Oncology Hematology Associates
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Mishawaka, Indiana, United States, 46544
    - Memorial Regional Cancer Center Day Road
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - Valparaiso, Indiana, United States, 46383
    - Porter Memorial Hospital
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Fairfield, Iowa, United States, 52556
    - JCHC McCreery Cancer Center
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Mason City, Iowa, United States, 50401
    - Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - Ottumwa Regional Health Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Prairie Village, Kansas, United States, 66208
    - Kansas City NCI Community Oncology Research Program
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Topeka, Kansas, United States, 66604
    - Stormont-Vail Regional Health Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Corbin, Kentucky, United States, 40701
    - Baptist Health Corbin
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
  - Elizabethtown, Kentucky, United States, 42701
    - Hardin Memorial Hospital
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
  - Louisville, Kentucky, United States, 40207
    - Baptist Health Louisville
  - Madisonville, Kentucky, United States, 42431
    - Baptist Health Madisonville/Merle Mahr Cancer Center
  - Owensboro, Kentucky, United States, 42303
    - Owensboro Health Mitchell Memorial Cancer Center
  - Paducah, Kentucky, United States, 42003
    - Baptist Health Paducah
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Christus Saint Frances Cabrini Hospital
  - Monroe, Louisiana, United States, 71202
    - University Health-Conway
  - Shreveport, Louisiana, United States, 71103
    - Louisiana State University Health Sciences Center Shreveport
  - Shreveport, Louisiana, United States, 71105
    - CHRISTUS Highland Medical Center
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
  - Rockport, Maine, United States, 04856
    - Penobscot Bay Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21244
    - Kaiser Permanente-Woodlawn Medical Center
  - Bethesda, Maryland, United States, 20814
    - Suburban Hospital
  - Frederick, Maryland, United States, 21701
    - Frederick Memorial Hospital
  - Gaithersburg, Maryland, United States, 20879
    - Kaiser Permanente-Gaithersburg Medical Center
  - Largo, Maryland, United States, 20774
    - Kaiser Permanente - Largo Medical Center
- Massachusetts
  - Attleboro, Massachusetts, United States, 02703
    - Sturdy Memorial Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Brighton, Massachusetts, United States, 02135
    - Steward Saint Elizabeth's Medical Center
  - Fall River, Massachusetts, United States, 02721
    - Saint Anne's Hospital
  - Fitchburg, Massachusetts, United States, 01420
    - Simonds-Sinon Regional Cancer Center
  - Newton, Massachusetts, United States, 02462
    - Newton-Wellesley Hospital
  - Norwood, Massachusetts, United States, 02062
    - Norwood Hospital
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Medical School
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Bay City, Michigan, United States, 48706
    - McLaren-Bay Region
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Clarkston, Michigan, United States, 48346
    - Great Lakes Cancer Institute
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital-Dearborn
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48532
    - Singh and Arora Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Cancer Research Consortium of West Michigan NCORP
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Lansing, Michigan, United States, 48910
    - McLaren-Greater Lansing
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Midland, Michigan, United States, 48670
    - Mid-Michigan Medical Center - Midland
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, United States, 48858
    - McLaren Cancer Institute-Central Michigan
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Community Hospital
  - Petoskey, Michigan, United States, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Southfield, Michigan, United States, 48075
    - Providence Hospital-Southfield Cancer Center
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Troy, Michigan, United States, 48098
    - William Beaumont Hospital - Troy
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Clinic North-Bemidgi
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
  - Oxford, Mississippi, United States, 38655
    - Family Cancer Center-Oxford
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
  - Southaven, Mississippi, United States, 38671
    - Family Cancer Center-Southhaven
  - Southhaven, Mississippi, United States, 38671
    - Baptist Memorial Hospital-Desoto
- Missouri
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, United States, 65616
    - CoxHealth Cancer Center
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital-Joplin
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium NCORP
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, United States, 68506
    - Nebraska Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Lincoln, Nebraska, United States, 68510
    - Southeast Nebraska Cancer Center
  - Norfolk, Nebraska, United States, 68701
    - Faith Regional Medical Offices West
  - North Platte, Nebraska, United States, 69103
    - Great Plains Regional Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West PC
  - Omaha, Nebraska, United States, 68130
    - Urology Cancer Center PC
  - Omaha, Nebraska, United States, 68124
    - Oncology Hematology West
  - Scottsbluff, Nebraska, United States, 69361
    - Regional West Medical Center
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - 21st Century Oncology - Henderson
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89109
    - 21st Century Oncology
  - Las Vegas, Nevada, United States, 89148
    - Cancer and Blood Specialists-Fort Apache
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
  - Las Vegas, Nevada, United States, 89148
    - 21st Century Oncology - Fort Apache
  - Las Vegas, Nevada, United States, 89182
    - 21st Century Oncology - Vegas Tenaya
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Alpine Hematology-Oncology
  - Reno, Nevada, United States, 89519
    - Reno Oncology Consultants
- New Hampshire
  - Dover, New Hampshire, United States, 03820
    - Wentworth-Douglass Hospital
  - Portsmouth, New Hampshire, United States, 03802
    - Portsmouth Regional Hospital
- New Jersey
  - Egg Harbor Township, New Jersey, United States, 08234
    - AtlantiCare Surgery Center
  - New Brunswick, New Jersey, United States, 08901
    - Saint Peter's University Hospital
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Pennington, New Jersey, United States, 08534
    - Capital Health Medical Center-Hopewell
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
  - Woodbury, New Jersey, United States, 08096
    - Inspira Medical Center Woodbury
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
- New York
  - Auburn, New York, United States, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - Bronx, New York, United States, 10451
    - Lincoln Medical and Mental Health Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Cooperstown, New York, United States, 13326
    - Mary Imogene Bassett Hospital
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Elmhurst, New York, United States, 11373
    - Elmhurst Hospital Center
  - Elmira, New York, United States, 14905
    - Arnot Ogden Medical Center/Falck Cancer Center
  - Jamaica, New York, United States, 11432
    - Queens Hospital Center
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - New York, New York, United States, 10032
    - Columbia University/Herbert Irving Cancer Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rome, New York, United States, 13440
    - Hematology Oncology Associates of Central New York-Rome
  - Staten Island, New York, United States, 10305
    - Staten Island University Hospital
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Associates of Central New York-Onondaga Hill
  - White Plains, New York, United States, 10601
    - Dickstein Cancer Treatment Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28816
    - Hope Women's Cancer Centers-Asheville
  - Asheville, North Carolina, United States, 28801
    - Cancer Care of Western North Carolina
  - Asheville, North Carolina, United States, 28801
    - Mission Hospital-Memorial Campus
  - Belmont, North Carolina, United States, 28012
    - Gaston Hematology and Oncology Associates-Belmont
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Gastonia, North Carolina, United States, 28054
    - CaroMont Regional Medical Center
  - Gastonia, North Carolina, United States, 28054
    - Gaston Hematology and Oncology Associates
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Hendersonville, North Carolina, United States, 28791
    - Hendersonville Hematology and Oncology at Pardee
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Hendersonville, North Carolina, United States, 28792
    - Park Ridge Hospital Breast Health Center
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kernersville, North Carolina, United States, 27284
    - Novant Health Oncology Specialists-Kernersville
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Leland, North Carolina, United States, 28451
    - Cape Fear Cancer Specialists-Leland
  - Mount Airy, North Carolina, United States, 27030
    - Novant Health Oncology Specialists-Mount Airy
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hosiptal
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Salisbury, North Carolina, United States, 28144
    - Carolina Oncology Associates PA
  - Shelby, North Carolina, United States, 28150
    - Cleveland Hematology and Oncology Associates PC
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Statesville, North Carolina, United States, 28625
    - Novant Health Oncology Specialists-Statesville
  - Thomasville, North Carolina, United States, 27360
    - Novant Health Oncology Specialists-Davidson County
  - Washington, North Carolina, United States, 27889
    - Marion L Shepard Cancer Center at Vidant Beaufort Hospital
  - Wilkesboro, North Carolina, United States, 28659
    - Novant Health Oncology Specialists-Wilkesboro
  - Wilmington, North Carolina, United States, 28401
    - New Hanover Regional Medical Center/Zimmer Cancer Center
  - Wilmington, North Carolina, United States, 28401
    - Cape Fear Cancer Specialists
  - Wilson, North Carolina, United States, 27893
    - Southeastern Medical Oncology Center-Wilson
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Forsyth Medical Center
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Oncology Specialists
  - Winston-Salem, North Carolina, United States, 27103
    - Winston-Salem Health Care
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, United States, 58122
    - Sanford Medical Center-Fargo
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc - Anderson
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45420
    - Dayton NCI Community Oncology Research Program
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OneHealth Marion General Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
  - Tulsa, Oklahoma, United States, 74146
    - Warren Clinic Oncology-Tulsa
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Corvallis, Oregon, United States, 97330
    - Good Samaritan Hospital
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Doylestown, Pennsylvania, United States, 18901
    - Doylestown Hospital
  - Easton, Pennsylvania, United States, 18042
    - Easton Hospital
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology-Lewisburg
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - Meadowbrook, Pennsylvania, United States, 19046
    - Holy Redeemer Hospital and Medical Center
  - Phoenixville, Pennsylvania, United States, 19460
    - Phoenixville Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Medical Center
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Medical Oncology-Pottsville
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - West Chester, Pennsylvania, United States, 19380
    - Chester County Hospital
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Williamsport, Pennsylvania, United States, 17701
    - Susquehanna Cancer Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Beaufort, South Carolina, United States, 29902
    - Beaufort Memorial Hospital
  - Charleston, South Carolina, United States, 29401
    - Roper Hospital
  - Charleston, South Carolina, United States, 29403
    - Charleston Hematology Oncology Associates-Roper
  - Charleston, South Carolina, United States, 29406
    - Lowcountry Hematology Oncology PA-North Charleston
  - Charleston, South Carolina, United States, 29414
    - Charleston Hematology Oncology Associates PA-St. Francis
  - Charleston, South Carolina, United States, 29414
    - Lowcountry Hematology Oncology PA-West Ashley
  - Easley, South Carolina, United States, 29640
    - Greenville Health System Cancer Institute-Easley
  - Florence, South Carolina, United States, 29506
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Andrews
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Healthcare
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Mount Pleasant, South Carolina, United States, 29464
    - Lowcountry Hematology Oncology PA-Mount Pleasant
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center-Oncology Clinic
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - Boston Baskin Cancer Center-Bartlett
  - Memphis, Tennessee, United States, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Memphis, Tennessee, United States, 38120
    - Family Cancer Center-Memphis
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - El Paso, Texas, United States, 79905
    - Texas Technology University
  - Laredo, Texas, United States, 78041
    - Doctor's Hospital of Laredo
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84107
    - Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center
  - Saint George, Utah, United States, 84770
    - Dixie Medical Center Regional Cancer Center
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
- Vermont
  - Berlin, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05405
    - University of Vermont College of Medicine
- Virginia
  - Burke, Virginia, United States, 22015
    - Kaiser Permanente-Burke Medical Center
  - Charlottesville, Virginia, United States, 22901
    - Sentara Martha Jefferson Hospital
  - Fairfax, Virginia, United States, 22031
    - IMG Hematology Oncology 8501
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - McLean, Virginia, United States, 22102
    - Kaiser Permanente Tysons Corner Medical Center
  - Midlothian, Virginia, United States, 23114
    - Bon Secours Saint Francis Medical Center
  - Richmond, Virginia, United States, 23226
    - Bon Secours Saint Mary's Hospital
- Washington
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Auburn, Washington, United States, 98001
    - MultiCare Auburn Medical Center
  - Bainbridge Island, Washington, United States, 98110
    - Virginia Mason Bainbridge Island Medical Center
  - Bellevue, Washington, United States, 98004
    - Overlake Hospital Medical Center
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Edmonds, Washington, United States, 98026
    - Swedish Medical Center-Edmonds
  - Federal Way, Washington, United States, 98002
    - Virginia Mason Federal Way Medical Center
  - Gig Harbor, Washington, United States, 98332
    - Tacoma/Valley Radiation Oncology Centers-Gig Harbor
  - Gig Harbor, Washington, United States, 98335
    - MultiCare Gig Harbor Medical Park
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Kennewick, Washington, United States, 99336
    - Northwest Cancer Clinic
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Lynnwood, Washington, United States, 98036
    - Virginia Mason Lynnwood Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Poulsbo, Washington, United States, 98370
    - Peninsula Cancer Center
  - Puyallup, Washington, United States, 98372
    - MultiCare Good Samaritan Hospital
  - Puyallup, Washington, United States, 98372
    - Tacoma/Valley Radiation Oncology Centers-Puyallup
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98104
    - Minor and James Medical PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Cooperative-Seattle
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Sedro-Woolley, Washington, United States, 98284
    - United General Hospital
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology PS
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - Tacoma/Valley Radiation Oncology Centers-Saint Joe's
  - Tacoma, Washington, United States, 97405
    - Tacoma/Valley Radiation Oncology Centers-Jackson Hall
  - Tacoma, Washington, United States, 98405
    - Northwest NCI Community Oncology Research Program
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Fond Du Lac, Wisconsin, United States, 54935
    - Saint Agnes Hospital/Agnesian Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Janesville, Wisconsin, United States, 53547
    - Mercy Health System
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Milwaukee, Wisconsin, United States, 53210
    - Wheaton Franciscan Healthcare - Saint Joseph
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Sheboygan, Wisconsin, United States, 53081
    - HSHS Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic Cancer Care at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus UW Cancer Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Cheyenne, Wyoming, United States, 82001
    - Cheyenne Regional Medical Center-West
  - Cody, Wyoming, United States, 82414
    - Big Horn Basin Cancer Center
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

Patients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery
Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF) within 7 days prior to registration; patients must have an "average pain" of at least 4 on the BPI-SF

PATIENT CHARACTERISTICS:

Patients must be post-menopausal, as defined by at least one of the following:
- At least 12 months since the last menstrual period
- Prior bilateral oophorectomy
- Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post menopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration OR
- Have been on LHRH agonist therapy for at least 3 months and estradiol levels drawn within 28 days prior to registration are consistent with the institutional normal values for post-menopausal state.
Patients must have Zubrod performance status of 0-2
Patients must have no known allergy or hypersensitivity to duloxetine or any of the inactive ingredients in the matching placebo
Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:
- Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
- History of alcohol or other substance abuse or dependence within 365 days prior to registration
- Chronic liver disease
- End-stage renal disease
- Uncontrolled narrow-angle glaucoma
- Clinically significant coagulation disorder
Creatinine clearance > 30 mL/min
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x upper limit of normal
Total bilirubin within the upper limit of normal
Patients must be able to complete study questionnaires in English or Spanish
Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone
Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
If patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration
Concurrent bisphosphonate and trastuzumab therapies are allowed
Patients should have recovered from all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy
Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days, but no longer than 12 months, prior to registration and plans to continue for at least an additional 180 days after registration
- Anastrozole (Arimidex®) 1 mg daily
- Letrozole (Femara®) 2.5 mg daily
- Exemestane (Aromasin®) 25 mg daily
Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: treatment with phenothiazines, propafenone, flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14 days prior to registration; or current use of anticoagulation medication (e.g., heparin, warfarin)
Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration; patients must not have taken duloxetine or milnacipran within 90 days prior to registration
Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.	Drug: duloxetine hydrochloride Given PO Other Names: NSC-744012
PLACEBO_COMPARATOR: Arm II Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.	Other: placebo Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Joint Pain According to BPI-SF Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported	Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".	Weeks 2, 6, 12, and 24; Week 12 reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Joint Pain According to the BPI-SF Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported	Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".	Weeks 2, 6, 12, and 24; Week 12 reported
Pain Interference According to the BPI-SF Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported	Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".	Weeks 2, 6, 12, and 24; Week 12 reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: N. Lynn Henry, MD, PhD, University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Henry NL, Unger JM, Schott AF, Fehrenbacher L, Flynn PJ, Prow DM, Sharer CW, Burton GV, Kuzma CS, Moseley A, Lew DL, Fisch MJ, Moinpour CM, Hershman DL, Wade JL 3rd. Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. J Clin Oncol. 2018 Feb 1;36(4):326-332. doi: 10.1200/JCO.2017.74.6651. Epub 2017 Nov 14.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 20, 2018

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (ESTIMATE)

May 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

S1202 (OTHER: SWOG)
U10CA037429 (U.S. NIH Grant/Contract)
NCI-2012-01960 (OTHER: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://swog.org/Visitors/Download/Policies/Policy43.pdf

Study Data/Documents

Individual Participant Data Set
Information comments: Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Clinical Trials on Pain

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations