- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363909
Citalopram in Treating Postmenopausal Women With Hot Flashes
Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women.
PURPOSE: This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer.
Secondary
- Compare the side effect profile of these regimens in these patients.
- Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes.
- Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), tamoxifen (yes vs no), selective estrogen-receptor modulators (SERMs) (yes vs no), aromatase inhibitors (yes vs no), duration of hot flashes (< 9 months vs ≥ 9 months), and frequency of hot flashes per day (< 4 vs 4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.
- Arm I (low-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in weeks 2-7.
- Arm II (medium-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7.
- Arm III (high-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7.
- Arm IV (placebo): Patients receive 1-3 placebo tablets once daily in weeks 2-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
A Symptom Experience diary is completed weekly and Profile of Mood States and Hot Flash-Related Interference Scale questionnaires are completed at baseline and in week 7.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Georgia
-
Augusta, Georgia, United States, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
-
Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
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Canton, Illinois, United States, 61520
- Graham Hospital
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Carthage, Illinois, United States, 62321
- Memorial Hospital
-
Eureka, Illinois, United States, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Clinic
-
Havana, Illinois, United States, 62644
- Mason District Hospital
-
Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Kewanee, Illinois, United States, 61443
- Kewanee Hospital
-
Macomb, Illinois, United States, 61455
- McDonough District Hospital
-
Normal, Illinois, United States, 61761
- BroMenn Regional Medical Center
-
Normal, Illinois, United States, 61761
- 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
-
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
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
-
Kokomo, Indiana, United States, 46904
- Howard Community Hospital at Howard Regional Health System
-
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
-
Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services, Incorporated
-
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
- Saint Joseph Regional Medical Center
-
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Iowa
-
Ames, Iowa, United States, 50010
- McFarland Clinic, PC
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
-
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
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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
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Des Moines, Iowa, United States, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, United States, 50316-2301
- John Stoddard Cancer Center
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Mason City, Iowa, United States, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, United States, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
-
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Kansas
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, PA - Chanute
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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
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, United States, 67901
- Southwest Medical Center
-
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, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, United States, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States, 67214
- CCOP - Wichita
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Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
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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
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Escanaba, Michigan, United States, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
-
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 Hospital
-
Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
-
Lansing, Michigan, United States, 48909
- Sparrow Regional Cancer Center
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Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital System
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Saginaw, Michigan, United States, 48601
- Seton Cancer Institute - Saginaw
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St. Joseph, Michigan, United States, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Warren, Michigan, United States, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, United States, 56308
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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
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, United States, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, United States, 56537
-
Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Mankato, Minnesota, United States, 56002
- Immanuel St. Joseph's Clinic
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
-
Montevideo, Minnesota, United States, 56265
- Chippewa County - Montevideo Hospital
-
Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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St. Cloud, Minnesota, United States, 56303
- CentraCare Clinic - River Campus
-
St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, United States, 55102
- United Hospital
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Missouri
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Saint Louis, Missouri, United States, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care Research
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St. Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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-
Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, United States, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, United States, 59101
- St. Vincent Healthcare
-
Billings, Montana, United States, 59107-5100
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59107-7000
- Deaconess Billings Clinic - Downtown
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, United States, 59701
- St. James Community Hospital
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic
-
Great Falls, Montana, United States, 59405
-
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
-
Missoula, Montana, United States, 59801
- Community Medical Center
-
Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
-
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
-
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Nebraska
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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
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Omaha, Nebraska, United States, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, United States, 68131-2197
- Creighton University Medical Center
-
-
North Carolina
-
Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
-
-
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
-
-
Ohio
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Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
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, 43228
- Doctors Hospital at Ohio Health
-
Columbus, Ohio, United States, 43215
- Grant Riverside Cancer Services
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
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, 45429
- CCOP - Dayton
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, United States, 43420
- Fremont Memorial 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
-
Marietta, Ohio, United States, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, United States, 43537
- St. Luke's Hospital
-
Middletown, Ohio, United States, 45044
- Middletown Regional Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, United States, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, United States, 45505
- Community Hospital of Springfield and Clark County
-
Springfield, Ohio, United States, 45504
- Mercy Medical Center
-
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
-
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 Cancer Services at Mount Carmel St. Ann's Hospital
-
Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Zanesville, Ohio, United States, 43701
- Genesis - Good Samaritan Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822-0001
- Geisinger Medical 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
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, United States, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
-
-
Virginia
-
Fredericksburg, Virginia, United States, 22401
- Hematology-Oncology Associates of Fredericksburg, Incorporated
-
-
Wisconsin
-
Fond du Lac, Wisconsin, United States, 54935
- Central Wisconsin Cancer Program at Agnesian HealthCare
-
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
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Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, United States, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Marinette, Wisconsin, United States, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, United States, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, United States, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
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Wyoming
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
History of breast cancer
- No current malignant disease
- No history of breast cancer and refused estrogen replacement therapy due to perceived increased risk of breast cancer
- Bothersome hot flashes, defined as hot flashes ≥ 14 times/week and of sufficient severity to make the patient desire therapeutic intervention
- Presence of hot flashes ≥ 1 month prior to study entry
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
Postmenopausal, as defined by 1 of the following criteria:
- Absence of a menstrual period in the past 12 months
- Bilateral oophorectomy
- Absence of a menstrual period in the past 6 months with follicle-stimulating hormone (FSH) level > 40 mIU/mL
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Willing to provide blood samples during study participation
- No history of allergic or other adverse reactions to citalopram hydrobromide or other selective serotonin reuptake inhibitors (SSRIs)
- No documented mania or hypomania
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior and no concurrent antineoplastic chemotherapy
- At least 4 weeks since prior and no concurrent androgens, estrogens, or progestational agents
- At least 3 months since prior antidepressant use, including Hypericum perforatum (St. John's wort)
- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed if on a constant dose for ≥ 4 weeks and continuing medication during study period
No other concurrent or planned agents for treating hot flashes (e.g., phenobarbital, megestrol, or clonidine)
- Stable dose of vitamin E allowed as long as it was started > 30 days prior to study entry
- Concurrent soy allowed
- Concurrent gabapentin allowed for reasons other than hot flashes if on a constant dose for ≥ 1 month and continuing during study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in weeks 2-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies. |
|
Experimental: medium-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies. |
|
Experimental: high-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies. |
|
Placebo Comparator: placebo
Patients receive 1-3 placebo tablets once daily in weeks 2-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in average hot flash score from baseline until week 7 of treatment
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
Mood- and hot flash-related daily interference with activities
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hot Flashes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Citalopram
- Dexetimide
Other Study ID Numbers
- NCCTG-N05C9
- NCI-2012-02699 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000489567 (Registry Identifier: PDQ (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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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States