Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer

Inclusion 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)