Breast Cancer Clinical Trial
St. John’s Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
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.
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.
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)
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There are 19 Locations for this study
Newark Delaware, 19713, United States
Washington District of Columbia, 20060, United States
Miami Florida, 33136, United States
Decatur Illinois, 62526, United States
South Bend Indiana, 46601, United States
Shreveport Louisiana, 71130, United States
Ann Arbor Michigan, 48106, United States
Royal Oak Michigan, 48073, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Burlington North Carolina, 27216, United States
Elkin North Carolina, 28621, United States
Goldsboro North Carolina, 27534, United States
Greenville North Carolina, 27835, United States
Winston-Salem North Carolina, 27157, United States
Greenville South Carolina, 29615, United States
Hilton Head Island South Carolina, 29925, United States
Spartanburg South Carolina, 29303, United States
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