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

Phase 2TerminatedNCT00110136

Wake Forest University Health Sciences9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Hot Flashes

Interventions

St. John's WortDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (19)

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, United States

Outcomes

Primary Outcomes

Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks

Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort

Time frame: Baseline and four weeks

Secondary Outcomes

Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks

The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week. Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days. Score ranges from 0 to infinity Lower scores are better.

Time frame: Baseline and four weeks

Estimation of Toxicities While on St. John's Wort

Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.

Time frame: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)

Effect of St. John's Wort on Quality of Life (MCS)

Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS. SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric. MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health. The range is 0 to 100. Higher scores represent better mental health.

Time frame: Baseline and four weeks

Effect of St. John's Wort on Quality of Life (PCS)

Data from ClinicalTrials.gov

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