Status:
TERMINATED
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 activi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 16 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00110136
Start Date
March 16 2006
End Date
April 1 2008
Last Update
September 29 2021
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States, 19713
2
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States, 20060
3
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
4
CCOP - Central Illinois
Decatur, Illinois, United States, 62526