Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
NCT ID: NCT00060320
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
132 participants
INTERVENTIONAL
2003-10-31
2006-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
black cohosh
placebo
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.
black cohosh
placebo
Interventions
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black cohosh
placebo
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Barbara A. Pockaj, MD
Role: STUDY_CHAIR
Mayo Clinic Hospital
Locations
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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Countries
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References
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Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, Lavasseur BI, Rao RM, Fitch TR, Rowland KM, Novotny PJ, Flynn PJ, Richelson E, Fauq AH. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol. 2006 Jun 20;24(18):2836-41. doi: 10.1200/JCO.2005.05.4296.
Other Identifiers
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CDR0000301615
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N01CC
Identifier Type: -
Identifier Source: org_study_id
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