- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00060320
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5404
- CCOP - Mayo Clinic Scottsdale Oncology Program
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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-
Iowa
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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-
Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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-
Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, United States, 58501-5505
- Medcenter One Health System
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: black cohost
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. |
|
Placebo Comparator: placebo
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hot flash activity
Time Frame: Up to 3.5 years
|
Up to 3.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of hot flash score
Time Frame: Up to 3.5 years
|
Up to 3.5 years
|
Quality of life
Time Frame: Up to 3.5 years
|
Up to 3.5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Barbara A. Pockaj, MD, Mayo Clinic Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCTG-N01CC
- CDR0000301615 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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