Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Breast Cancer, Hot Flashes
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring stage IV breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, hot flashes
Eligibility Criteria
DISEASE CHARACTERISTICS: History of breast cancer OR concern about taking hormones because of fear of breast cancer No current active disease No current evidence of malignant disease Bothersome hot flashes Patient-reported occurrence at least 14 times per week and of sufficient severity to make the patient desire therapeutic intervention Hormone receptor status: PATIENT CHARACTERISTICS: Age 18 and over Sex Female Performance status ECOG 0-1 Life expectancy At least 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to complete questionnaires alone or with assistance PRIOR CONCURRENT THERAPY: Chemotherapy More than 4 weeks since prior antineoplastic chemotherapy No concurrent antineoplastic chemotherapy during the double-blind portion of the study Endocrine therapy More than 4 weeks since prior androgens, estrogens, or progestational agents More than 2 weeks since prior dehydroepiandrosterone (DHEA) for hot flashes No concurrent androgens, estrogens, or progestational agents during the double-blind portion of the study No concurrent DHEA for hot flashes Concurrent tamoxifen, raloxifene, or an aromatase inhibitor is allowed provided the patient started the drug at least 4 weeks prior to study entry and plans to continue the drug throughout the double-blind portion of the study Other More than 2 weeks since prior antidepressants More than 2 weeks since other prior agents for treating hot flashes (e.g., clonidine or Bellergal-s) No prior black cohosh No concurrent antidepressants during the double-blind portion of the study No other concurrent agents for treating hot flashes (e.g., clonidine or Bellergal-s) Concurrent vitamin E and/or soy allowed provided patient is on a stable dose for at least 1 month prior to study entry and plans to continue the same dose throughout study duration No concurrent oral herbal therapies or therapeutic herbal teas or tinctures except beverage teas (e.g., chamomile, ginger, peppermint, lemongrass, and fruit-based tea)
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Mayo Clinic
- CCOP - Carle Cancer Center
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Michigan Cancer Research Consortium
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- CCOP - Merit Care Hospital
- CCOP - Sioux Community Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
black cohost
placebo
Patients receive oral black cohosh twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment for 4 weeks. After completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks. Patients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment. Patients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.
Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment for 4 weeks. After completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks. Patients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment. Patients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.