St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
- Registration Number
- NCT00110136
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description St. John's Wort St. John's Wort Patient given one 300mg St. John's Wort tablet three times per day
- Primary Outcome Measures
Name Time Method Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Baseline and four weeks Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort
- Secondary Outcome Measures
Name Time Method Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Baseline and four weeks The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.
Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.
Score ranges from 0 to infinity
Lower scores are better.Estimation of Toxicities While on St. John's Wort Six weeks following baseline (four weeks of active treatment and two weeks of follow-up) Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.
Effect of St. John's Wort on Quality of Life (PCS) Baseline and four weeks Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.
SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.
PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.
The range is 0 to 100.
Higher scores represent better mental health.Mood is Measured by the POMS Short Form. Baseline and four weeks POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).
Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.
The range is 0 to 68.
Higher scores represent better overall mood.Effect of St. John's Wort on Quality of Life (MCS) Baseline and four weeks Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.
SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.
MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.
The range is 0 to 100.
Higher scores represent better mental health.
Trial Locations
- Locations (19)
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Hugh Chatham Memorial Hospital
🇺🇸Elkin, North Carolina, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Helen F. Graham Cancer Center at Christiana Hospital
🇺🇸Newark, Delaware, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Alamance Cancer Center at Alamance Regional Medical Center
🇺🇸Burlington, North Carolina, United States
South Carolina Cancer Specialists
🇺🇸Hilton Head Island, South Carolina, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States