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

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.