RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in women.

PURPOSE: Randomizedphase III trial to determine the effectiveness of black cohosh in relieving hot flashes in women who have breast cancer or who are at risk of developing breast cancer.

Condition	Treatment or Intervention	Phase
Breast Cancer Hot Flashes	Drug: black cohosh  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:
• 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)

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

Study chairs or principal investigators

Barbara A. Pockaj, MD,  Study Chair,  Mayo Clinic Scottsdale   

Study ID Numbers:  CDR0000301615; NCCTG-N01CC
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060320
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08