Breast Cancer Risk Biomarkers in Postmenopausal Women
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids|
- To determine the feasibility of an intervention of Lovaza™ 4 grams per day [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.
- To assess the potential efficacy [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]To assess the potential efficacy as demonstrated by significant modulation of 1 or more risk biomarkers
- To assess change in cell fatty acid signatures with Lovaza™ [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]To assess change in cell fatty acid signatures with Lovaza™ especially change in erythrocyte and breast tissue phospholipid EPA and DHA or the combination relative to Arachidonic Acid (AA) and correlate these changes with those in risk biomarkers, and mechanism of action biomarkers, and total oral intake.
- To measure change in quality of life with Lovaza™ [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]To measure change in quality of life with Lovaza™ and correlate with change if any with change in erythrocyte phospholipid fatty acid signatures particularly EPA:AA, DHA:AA, EPA +DHA:AA
|Study Start Date:||November 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Lovaza™ (two 1 gram capsules twice daily) for six months
4 capsules daily for 6 months
Other Name: esters of EPA and DHA
The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid esters [eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg] daily in the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice daily) will have a favorable side effect profile and potential efficacy as demonstrated by favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer in postmenopausal women.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252290
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|