A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
- 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
- Determine hot flash changes over 4 weeks in patients treated with this drug.
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks
Michelle Naughton, PhD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|MBCCOP - Howard University Cancer Center||Washington, District of Columbia 20060|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|Hugh Chatham Memorial Hospital||Elkin, North Carolina 28621|
|Helen F. Graham Cancer Center at Christiana Hospital||Newark, Delaware 19718|
|South Carolina Cancer Specialists||Hilton Head Island, South Carolina 29925|