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Home > "B" Clinical Trials Conditions > Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer  Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
For Condition: Hot Flashes,Breast Cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in women. PURPOSE: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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: - 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraPockaj, Study Chair, Mayo Clinic Scottsdale
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Barbara Pockaj 480-301-8000
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-4918
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Additional Information:
Study ID Numbers: CDR0000301615; NCCTG-N01CC
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060320
Other Hot Flashes Studies:
1. Morbidity after Diagnosis and Treatment of Breast Cancer Patients
2. Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
3. An investigational drug (CAL) versus zoledronic acid (Zometa®) in patients with breast cancer
4. Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer Who Are Eligible For Tamoxifen Therapy
5. Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
Related Studies:
Other Hot Flashes Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
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