St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer

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 ≥ 2years
• 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 thatthe 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 hotflashes
• No concurrent corticosteroids Radiotherapy
• Not specified Surgery
• Not specified Other
• More than 14 days since prior Hypericum perforatum (St. John's wort), monoamineoxidase 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 orbellamine)