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

You may be eligible if

• 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)