Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women
Hot Flashes
About this trial
This is an interventional supportive care trial for Hot Flashes focused on measuring hot flashes
Eligibility Criteria
DISEASE CHARACTERISTICS: History of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ (currently without evidence of malignant disease) OR Concerns about taking estrogen for fear of breast cancer Bothersome hot flashes, defined as occurrence at least 14 times per week and of sufficient severity as to make patient desire therapeutic intervention Presence of hot flashes for at least 1 month Hormone receptor status: PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Performance status: ECOG 0-1 Life expectancy: At least 6 months Cardiovascular: No prior thromboembolic disease No uncontrolled hypertension (persistent diastolic blood pressure greater than 95 mm Hg and/or systolic blood pressure greater than 160 mm Hg) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy: More than 4 weeks since prior antineoplastic chemotherapy No concurrent antineoplastic chemotherapy unless clinically appropriate Endocrine therapy: More than 4 weeks since prior androgen or estrogen therapy More than 3 months since prior progesterone as part of hormone replacement therapy At least 1 year since any other progesterone therapy (including megestrol) No concurrent androgen, estrogen, or progestational agents unless clinically appropriate Concurrent tamoxifen, raloxifene, or aromatase inhibitors are allowed if started more than 4 weeks ago and continuation for more than 5 weeks is planned Other: More than 2 weeks since prior agents for treatment of hot flashes (e.g., clonidine, Bellergal-S, or vitamin E of more than 400 mg per day) More than 1 year since prior antidepressants (including Hypericum perforatum [St John's Wort]) No other concurrent antidepressants or monoamine oxidase inhibitors No other concurrent agents for treatment of hot flashes (e.g. clonidine, Bellergal-S, or vitamin E of more than 400 mg per day)
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Mayo Clinic - Jacksonville
- MBCCOP - Hawaii
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Michigan Cancer Research Consortium
- CCOP - Duluth
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- CCOP - Toledo Community Hospital
- CCOP - Oklahoma
- Allegheny General Hospital
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I: venlafaxine
Arm II: medroxyprogesterone - long term
Arm III: medroxyprogesterone - short term
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive oral venlafaxine once daily for 6 weeks beginning on day 8. After week 7, patients with satisfactory efficacy may continue venlafaxine for up to 6 months. Patients with unsatisfactory efficacy may cross over to arm III. Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone intramuscularly (IM) on days 8, 22, and 36 for a total of 3 injections. After week 7, patients with unsatisfactory efficacy may cross over to arm I. Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone IM once on day 8. After week 7, patients with unsatisfactory efficacy may cross over to arm I. Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.