A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
18 Years
N/A
Female
Breast Cancer, Hot Flashes
Trial Information
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.
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Barbara A. Pockaj, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000301615
NCT ID:
NCT00060320
Start Date:
October 2003
Completion Date:
Related Keywords:
- Breast Cancer
- Hot Flashes
- 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
- Breast Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| 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 |
