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Phase III Randomized Study of Black Cohosh for the Management of Hot Flashes in Women With Breast Cancer OR Who Have Concerns About Developing Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Alternate Title
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Supportive care | Completed | 18 and over | NCCTG-N01CC
N01CC, NCT00060320 |
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.
Entry 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:
Prior/Concurrent Therapy:
Biologic 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
Radiotherapy Surgery 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)
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic Renal Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to complete questionnaires alone or with assistance
Expected Enrollment A total of 110 patients (55 patients per arm) will be accrued for this study within 6-11 months. 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. Published ResultsPockaj BA, Gallagher JG, Loprinzi CL, et al.: Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol 24 (18): 2836-41, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | | Barbara Pockaj, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes | | | Trial Start Date | | 2003-10-03 | | | Registered in ClinicalTrials.gov | | NCT00060320 | | | Date Submitted to PDQ | | 2003-03-27 | | | Information Last Verified | | 2004-08-19 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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