A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
- 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
- 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
PROJECTED ACCRUAL: A total of 110 patients (55 patients per arm) will be accrued for this
study within 6-11 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Barbara A. Pockaj, MD
Mayo Clinic Hospital
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|