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

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.

PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest NCORP Research Base; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)

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)