Citalopram in Treating Postmenopausal Women With Hot Flashes
Breast Cancer, Hot Flashes, Psychosocial Effects of Cancer and Its Treatment
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring psychosocial effects of cancer and its treatment, hot flashes, breast cancer
Eligibility Criteria
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
Sites / Locations
- MBCCOP - Medical College of Georgia Cancer Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart General Hospital
- Howard Community Hospital at Howard Regional Health System
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- Seton Cancer Institute - Saginaw
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Immanuel St. Joseph's Clinic
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Arch Medical Services, Incorporated at Center for Cancer Care Research
- Missouri Baptist Cancer Center
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Community Hospital
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Wood County Oncology Center
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Geisinger Medical Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Hematology-Oncology Associates of Fredericksburg, Incorporated
- Central Wisconsin Cancer Program at Agnesian HealthCare
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
low-dose citalopram hydrobromide
medium-dose citalopram hydrobromide
high-dose citalopram hydrobromide
placebo
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.
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.
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.
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.