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



Status:Completed
Conditions:Breast Cancer, Cancer, Hot Flash
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:October 2003
End Date:June 2006

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

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.

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)
We found this trial at
13
sites
509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Ann Arbor, MI
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Bismarck, North Dakota 58501
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Bismarck, ND
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Des Moines, IA
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Fargo, North Dakota 58122
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Omaha, NE
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Saint Louis Park, Minnesota 55416
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Saint Louis Park, MN
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Scottsdale, AZ
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Sioux City, Iowa 51101
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Sioux City, IA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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Wichita, Kansas 67214
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Wichita, KS
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