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

OBJECTIVES:

Primary

- Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot
flashes, in terms of hot flash frequency, score, and duration and disruption of daily
activities caused by hot flashes, in postmenopausal women with non-metastatic breast
cancer.

- Determine hot flash changes over 4 weeks in patients treated with this drug.

Secondary

- Determine the toxicity of this drug in these patients.

- Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels
in women receiving tamoxifen therapy.

- Determine the effect of Hypericum perforatum (St. John's wort) on general health-related
quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week
post-treatment phase in these patients.

- To evaluate changes in average weekly hot flush scores and duration over course of
study.

OUTLINE: This is a multicenter study.

Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in
the absence of disease progression or unacceptable toxicity.

Patients complete a daily diary of the frequency, severity, and duration of their hot
flashes, and complete quality of life and mood assessments every 2 weeks during study
treatment and continuing weekly for 2 weeks after completion of study treatment.

Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at
baseline, 2, 4, and 6 weeks.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

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)