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

Study Overview
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Brief Summary
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RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in women. PURPOSE: Randomized phase 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.

Detailed Description
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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.

Official Title
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A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes

Conditions
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Breast Cancer, Hot Flashes

Intervention / Treatment
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* Dietary Supplement: black cohosh
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: black cohost<br>Patients receive oral black cohosh twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment 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. | Dietary Supplement: black cohosh<br> <br> Other: placebo<br> <br> |
| Placebo Comparator: placebo<br>Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment 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. | Dietary Supplement: black cohosh<br> <br> Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash activity |  | Up to 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hot flash score |  | Up to 3.5 years | 
| Quality of life |  | Up to 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, hot flashes