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

OBJECTIVES:

- Compare the efficacy of black cohosh vs placebo in diminishing hot flash activity in
women with breast cancer OR a concern about taking hormones because of a fear of breast
cancer.

- Determine whether continued use of this drug by these patients leads to prolonged
reduction of the hot flash score with minimal toxic effects.

- Correlate the reduction of hot flash score with improvement in quality of life and
related outcomes in patients treated with this drug.

- Determine the toxic effects of this drug in these patients.

- Determine whether abnormal sweating is decreased in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients
are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no
vs unknown), current raloxifene use (yes vs no vs unknown), current aromatase inhibitor use
(yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and
average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive oral black cohosh twice daily for 4 weeks.

- Arm II: Patients receive oral placebo twice daily for 4 weeks. All patients then cross
over to the other arm and receive treatment as above 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.

PROJECTED ACCRUAL: A total of 110 patients (55 patients per arm) will be accrued for this
study within 6-11 months.

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)