St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks [ Time Frame: One year ] [ Designated as safety issue: No ]
- Changes in hot flash scores and duration by hot flash diary at baseline and weeks 1-6 [ Time Frame: One year ] [ Designated as safety issue: No ]
- Toxicity at screening, baseline, week 2, week 4, and week 6 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Effects of St. John's wort on serum tamoxifen levels at screening, baseline, and weeks 2, 4, and 6 [ Time Frame: One year ] [ Designated as safety issue: No ]
- Quality of life by POMS and SF-12 at 2 and 4 weeks relative to baseline and during 2 week post-treatment phase [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||November 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: St. John's Wort
Patient given one 300mg St. John's Wort tablet three times per day
Drug: St. John's Wort
St. John's Wort 300mg tablet three times per day
Other Name: St. John's Wort
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110136
|United States, Delaware|
|Helen F. Graham Cancer Center at Christiana Hospital|
|Newark, Delaware, United States, 19713|
|United States, District of Columbia|
|MBCCOP - Howard University Cancer Center|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Indiana|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Louisiana|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Michigan|
|CCOP - Michigan Cancer Research Consortium|
|Ann Arbor, Michigan, United States, 48106|
|CCOP - Beaumont|
|Royal Oak, Michigan, United States, 48073-6769|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|St. Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65804|
|CCOP - St. Louis-Cape Girardeau|
|St. Louis, Missouri, United States, 63141|
|United States, North Carolina|
|Alamance Cancer Center at Alamance Regional Medical Center|
|Burlington, North Carolina, United States, 27216|
|Hugh Chatham Memorial Hospital|
|Elkin, North Carolina, United States, 28621|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|Leo W. Jenkins Cancer Center at ECU Medical School|
|Greenville, North Carolina, United States, 27835-6028|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|South Carolina Cancer Specialists|
|Hilton Head Island, South Carolina, United States, 29925|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Study Chair:||Michelle Naughton, PhD||Comprehensive Cancer Center of Wake Forest University|