St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
Breast Cancer, Hot Flashes
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, breast cancer in situ, ductal breast carcinoma in situ, hot flashes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Noninvasive ductal carcinoma in situ Localized breast cancer Stage 0-IIIB disease Locally recurrent breast cancer that is post-treatment AND disease-free for ≥ 2 years Experiencing ≥ 3 hot flashes per day (≥ 21 per week), defined by sweating, flushing, sensation of warmth, night sweats, and/or rapid heart beat of sufficient severity that the patient desires therapeutic intervention Normal mammogram within the past 10 months Hormone receptor status: Not specified INCLUSION CRITERIA: Age 18 and over Sex Female Menopausal status Post-menopausal (i.e., no menstrual periods ≥ 12 months or surgical menopause) Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin < 2 mg/dL SGOT ≤ 2 times normal Renal Not specified EXCLUSION CRITERIA: Not pregnant or nursing Fertile patients must use effective contraception No history of intolerance to St. John's wort PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy No concurrent selective estrogen-receptor modulators or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed Concurrent tamoxifen allowed No concurrent estrogen, progestational agents, or androgens for the alleviation of hot flashes No concurrent corticosteroids Radiotherapy Not specified Surgery Not specified Other More than 14 days since prior Hypericum perforatum (St. John's wort), monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (e.g., sertraline, paroxetine, or fluoxetine) or selective norepinephrine reuptake inhibitors (e.g., venlafaxine) No concurrent use of any of the following: Antidepressants Theophylline Warfarin, unless for central line prophylaxis Protease inhibitors for AIDS Digoxin Cyclosporine Benzodiazepines (e.g., diazepam or alprazolam) Calcium-channel blockers (e.g., diltiazem or nifedipine) Coenzyme A reductase inhibitors for serum cholesterol reduction Macrolide antibiotics (e.g., azithromycin, erythromycin, or clarithromycin) Griseofulvin Phenobarbital Phenytoin Rifampin Rifabutin Grapefruit juice Other naturopathic or herbal products Ketoconazole Fluconazole Itraconazole Rifabutin No other concurrent medications for the alleviation of hot flashes (e.g., clonidine or bellamine)
Sites / Locations
- Helen F. Graham Cancer Center at Christiana Hospital
- MBCCOP - Howard University Cancer Center
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- CCOP - Central Illinois
- CCOP - Northern Indiana CR Consortium
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- CCOP - Michigan Cancer Research Consortium
- CCOP - Beaumont
- CCOP - Metro-Minnesota
- CCOP - St. Louis-Cape Girardeau
- Cancer Research for the Ozarks
- Alamance Cancer Center at Alamance Regional Medical Center
- Hugh Chatham Memorial Hospital
- CCOP - Southeast Cancer Control Consortium
- Leo W. Jenkins Cancer Center at ECU Medical School
- Wake Forest University Comprehensive Cancer Center
- CCOP - Greenville
- South Carolina Cancer Specialists
- CCOP - Upstate Carolina
Arms of the Study
Arm 1
Experimental
St. John's Wort
Patient given one 300mg St. John's Wort tablet three times per day