Spots Global Cancer Trial Database for St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
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Trial Identification
Brief Title: St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
Official Title: A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer
Study ID: NCT00110136
Interventions
Study Description
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-metastatic breast cancer.
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 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Helen F. Graham Cancer Center at Christiana Hospital, Newark, Delaware, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
Cancer Research for the Ozarks, Springfield, Missouri, United States
Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina, United States
Hugh Chatham Memorial Hospital, Elkin, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Contact Details
Name: Michelle Naughton, PhD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
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