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

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Hot Flashes

Treatments: Drug: St. John's Wort

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00110136

U10CA081851 (U.S. NIH Grant/Contract)

REBACCCWFU 98301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

St. John's Wort

Experimental group

Description:

Patient given one 300mg St. John's Wort tablet three times per day

Treatment:

Drug: St. John's Wort