St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
Condition: Breast Cancer; Hot Flashes
MeSH terms: Breast Neoplasms; Hot Flashes
Intervention: St. John's Wort
Intervention description: St. John's Wort 300mg tablet three times per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

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)