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

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:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

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:

Biologic therapy

• Not specified

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

Radiotherapy

• Not specified

Surgery

• Not specified

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)