Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

March 16, 2017 updated by: Alliance for Clinical Trials in Oncology

A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.

Secondary

Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.
Describe the differences in duloxetine hydrochloride efficacy when used to treat pain caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and class.

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin vs other taxane agents without paclitaxel vs platinum agents [cisplatin] without oxaliplatin) and high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
Arm II: Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.

Patients complete pain and quality of life questionnaires, including the BPI-SF once weekly and FACT/GOG-NTX and EORTC QLQ-C30 questionnaires, in weeks 1, 6, 8, and 13.

After completion of study treatment, patients are followed for 2 weeks.

Study Type

Interventional

Enrollment (Actual)

231

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
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente - Deer Valley
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Comprehensive Cancer Center
  - Burlingame, California, United States, 94010
    - Peninsula 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
  - Concord, California, United States, 94524-4110
    - Cancer Care Center at John Muir Health - Concord Campus
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - La Jolla, California, United States, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Mountain View, California, United States, 94040
    - Camino Medical Group - Treatment Center
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Oakland, California, United States, 94611
    - Kaiser Permanente - Division of Research - Oakland
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation
  - Pismo Beach, California, United States, 93449
  - Rancho Cardova, California, United States, 95670
    - Kaiser Permanente Medical Center - Rancho Cordova
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Rohnert Park, California, United States, 94928
    - Rohnert Park Cancer Center
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Center at Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Cancer Center
  - Sacramento, California, United States, 95823
    - South Sacramento Cancer Center
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Diego, California, United States, 92120
    - Kaiser Permanente Medical Office -Vandever Medical Office
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - San Rafael, California, United States, 94903
    - Sutter Health - Western Division Cancer Research Group
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Clara, California, United States, 95051
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center - Vacaville
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
  - Walnut Creek, California, United States, 94598
    - John Muir/Mt. Diablo Comprehensive Cancer Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente - Denver
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente - Lafayette
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Greenwich, Connecticut, United States, 06830
    - Bendheim Cancer Center at Greenwich Hospital
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20307-5001
    - Walter Reed Army Medical Center
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  - Hollywood, Florida, United States, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jupiter, Florida, United States, 33458
    - Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803-1273
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida - Weston
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Rome, Georgia, United States, 30165
    - Harbin Clinic Cancer Center - Medical Oncology
  - Savannah, Georgia, United States, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Hawaii
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente - Moanalua Medical Center and Clinic
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, United States, 61701
    - Illinois CancerCare - Bloomington
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare - Carthage
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60612-3785
    - John H. Stroger, Jr. Hospital of Cook County
  - Chicago, Illinois, United States, 60631
    - Resurrection Medical Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare - Havana
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare - Kewanee Clinic
  - La Grange, Illinois, United States, 60525
    - La Grange Memorial Hospital
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Moline, Illinois, United States, 61265
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, United States, 61462
    - OSF Holy Family Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare - Princeton
  - Rockford, Illinois, United States, 61104-2315
    - Swedish-American Regional Cancer Center
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare - Spring Valley
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Central Dupage Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
  - Cedar Rapids, Iowa, United States, 52402
    - St. Luke's Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Cedar Rapids, Iowa, United States, 52402
    - Iowa Blood and Cancer Care
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Ottumwa, Iowa, United States, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - 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, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Ashland, Kentucky, United States, 41101-0151
    - Cancer Resource Center at King's Daughters Medical Center
  - Lexington, Kentucky, United States, 40503-9985
    - Central Baptist Hospital
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Easton, Maryland, United States, 21601
    - Shore Regional Cancer Center at Memorial Hospital - Easton
  - Elkton MD, Maryland, United States, 21921
    - Union Hospital Cancer Program at Union Hospital
- Massachusetts
  - Attleboro, Massachusetts, United States, 02703
    - Sturdy Memorial Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48532
    - Great Lakes Cancer Institute at McLaren Regional Medical Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lambertville, Michigan, United States, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Lansing, Michigan, United States, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Niles, Michigan, United States, 49120
    - Michiana Hematology Oncology PC - Niles
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital Cancer Care Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Fergus Falls Medical Group, PA
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care and Research
  - Saint Louis, Missouri, United States, 63109
    - Midwest Hematology Oncology Group, Incorporated
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care, PC
  - Saint Louis, Missouri, United States, 63128
    - St. Anthony's Cancer Center
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  - Exeter, New Hampshire, United States, 03833
    - Center for Cancer Care at Exeter Hospital
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology - Hematology, PA - Hooksett
  - Laconia, New Hampshire, United States, 03246
    - Lakes Region General Hospital
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  - Manchester, New Hampshire, United States, 03102
    - Norris Cotton Cancer Center at Catholic Medical Center
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - New Brunswick, New Jersey, United States, 08901
    - Saint Peter's University Hospital
  - Somerville, New Jersey, United States, 08876
    - Somerset Medical Center
  - Vineland, New Jersey, United States, 08360
    - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, PC at Albany Regional Cancer Care
  - Albany, New York, United States, 12208
    - New York Oncology Hematology, PC at Albany Medical Center
  - Amsterdam, New York, United States, 12010
    - Amsterdam Community Cancer Program
  - Brooklyn, New York, United States, 11209
    - Veterans Affairs Medical Center - Brooklyn
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Glens Falls, New York, United States, 12801
    - Charles R. Wood Cancer Center at Glens Falls Hospital
  - Hudson, New York, United States, 12534
    - New York Oncology Hematology, PC - Hudson
  - Jamaica, New York, United States, 11432
    - Queens Cancer Center of Queens Hospital
  - Latham, New York, United States, 12110
    - New York Oncology Hematology, PC - Latham
  - New York, New York, United States, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center
  - Rexford, New York, United States, 12148
    - Riverview Cancer Care Medical Associates, PC
  - Staten Island, New York, United States, 10305
    - Nalitt Cancer Institute at Staten Island University Hospital
  - Syracuse, New York, United States, 13210
    - Veterans Affairs Medical Center - Syracuse
  - Troy, New York, United States, 12180
    - Samaritan Hospital at Northeast Health
  - White Plains, New York, United States, 10601
    - Dickstein Cancer Treatment Center at White Plains Hospital Center
- North Carolina
  - Cary, North Carolina, United States, 27511
    - Waverly Hematology Oncology
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Concord, North Carolina, United States, 28025
    - Batte Cancer Center at Northeast Medical Center
  - Gastonia, North Carolina, United States, 28053
    - CaroMont Cancer Center at Gaston Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - High Point, North Carolina, United States, 27261
    - High Point Regional Hospital
  - High Point, North Carolina, United States, 27262
    - Emerywood Hematology/Oncology
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58122
    - MeritCare Broadway
  - Minot, North Dakota, United States, 58701
    - Trinity Cancercare Center
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, United States, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Barberton, Ohio, United States, 44203
    - Barberton Citizens Hospital
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Canton, Ohio, United States, 44710-1799
    - Aultman Cancer Center at Aultman Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Cancer Care Center at MetroHealth Medical Center
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care - Clyde
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - St. Luke's Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wright-Patterson Afb, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Doylestown, Pennsylvania, United States, 18901
    - Doylestown Hospital Cancer Center
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Hazleton Cancer Center
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Phoenixville, Pennsylvania, United States, 19460
    - Cancer Center at Phoenixville Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - Main Line Health
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Roper St. Francis Cancer Center at Roper Hospital
  - Florence, South Carolina, United States, 29501
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29605
    - Greenville Hospital Cancer Center
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Grove Commons
  - Greenville, South Carolina, United States, 29601
    - Bon Secours St. Francis Health System
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Cancer Center at Self Regional Medical Center
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Medical Oncology
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas - Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
- Texas
  - Fort Sam Houston, Texas, United States, 78234-6200
    - Brooke Army Medical Center
- Virginia
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital Cancer Care Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Martinsville, Virginia, United States, 24115
    - Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
  - Richmond, Virginia, United States, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
- West Virginia
  - Wheeling, West Virginia, United States, 26003
    - Schiffler Cancer Center at Wheeling Hospital
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Memorial Hospital of Burlington
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Elkhorn, Wisconsin, United States, 53121
    - Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
  - Franklin, Wisconsin, United States, 53132
    - Oncology Alliance - Franklin
  - Glendale, Wisconsin, United States, 53212-1038
    - Oncology Alliance, SC - Milwaukee - East
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Green Bay, Wisconsin, United States, 54311
    - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
  - Janesville, Wisconsin, United States, 53547
    - Mercy Regional Cancer Center
  - Kenosha, Wisconsin, United States, 53143
    - Oncology Alliance - Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - Madison, Wisconsin, United States, 53717
    - Dean Medical Center - Madison
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Vince Lombardi Cancer Clinic - Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Mequon, Wisconsin, United States, 53092
    - Aurora Advanced Healthcare East Mequon Clinic
  - Milwaukee, Wisconsin, United States, 53201-0342
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants, Limited
  - Milwaukee, Wisconsin, United States, 53215
    - Oncology Alliance, SC - Milwaukee - South
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Regional Cancer Center at Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406-5661
    - Aurora Health Center - Racine
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic - Sheboygan
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic - Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
  - Waukesha, Wisconsin, United States, 53188
    - Aurora Health Center - Waukesha
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic - Wausau Center
  - Wauwatosa, Wisconsin, United States, 53226
    - Oncology Alliance, SC - Milwaukee - West
  - West Allis, Wisconsin, United States, 53227
    - Aurora Women's Pavilion of West Allis Memorial Hospital
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

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

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Diagnosis of cancer
- CNS malignancy allowed with the exception of leptomeningeal carcinomatosis
Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes)
- CIPN > grade 1 as measured by NCI-CTCAE v 4.0
- Average neuropathic pain score ≥ 4
Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:
- Diabetes mellitus
- Peripheral vascular disease
- HIV infection
- Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy
No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)

PATIENT CHARACTERISTICS:

AST ≤ 3 times upper limit of normal
Total bilirubin ≤ normal
Creatinine clearance > 30 mL/min
Not pregnant or nursing
Able to take oral or enteral medication
No history of seizure disorder
No diagnosis of ethanol addiction or dependence within the past 10 years
No history of narrow-angle glaucoma
None of the following:
- History of suicidal thoughts
- Symptoms of or history of schizophrenia, bipolar disease, or a major depression
- Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely

PRIOR CONCURRENT THERAPY:

At least 3 months since prior and no concurrent taxane or platinum agent
At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants
No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)
No concurrent anticonvulsants
No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA)
- Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed
- Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E
No concurrent treatment (pharmacologic) for depression

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: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I/Group A (Duloxetine then Placebo) Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.	Other: placebo Given orally Drug: duloxetine hydrochloride Given orally
EXPERIMENTAL: Arm II/Group B (Placebo then Duloxetine) Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.	Other: placebo Given orally Drug: duloxetine hydrochloride Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item Time Frame: Day 1 of Week 1 to Day 1 of Week 6	Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.	Day 1 of Week 1 to Day 1 of Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score Time Frame: Day 1 of Week 1 to Day 1 to Week 6	Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.	Day 1 of Week 1 to Day 1 to Week 6
Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5 Time Frame: Day 1 of Week 1 to Day 1 of Week 6	Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.	Day 1 of Week 1 to Day 1 of Week 6
Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item Time Frame: Day 1 of Week 8 to Day 1 of Week 13	Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.	Day 1 of Week 8 to Day 1 of Week 13

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Ellen L. Smith, PhD, ARNP, AOCN, University of Michigan

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

Lavoie Smith EM, Pang H, Cirrincione C, et al.: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). [Abstract] J Clin Oncol 30 (Suppl 15): A-CRA9013, 2012.
Smith EM, Pang H, Ye C, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Le-Lindqwister N, Fadul CE, Loprinzi C, Shapiro CL; Alliance for Clinical Trials in Oncology. Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial - CALGB/alliance 170601. Eur J Cancer Care (Engl). 2017 Mar;26(2):10.1111/ecc.12421. doi: 10.1111/ecc.12421. Epub 2015 Nov 25.
Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.

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

April 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (ESTIMATE)

June 21, 2007

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CALGB-170601
CDR0000553389 (REGISTRY: NCI Physician Data Query)

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

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

Clinical Trials on Pain

Clinical Trials on placebo

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Conditions

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