Modulation of Breast Cancer Risk Biomarkers in Premenopausal Women by High Dose Omega-3 Fatty Acids
Overview
- Phase
- Phase 2
- Intervention
- Lovaza™
- Conditions
- Breast Cancer
- Sponsor
- Carol Fabian, MD
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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 premenopausal women.
Investigators
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lovaza™
Lovaza™ (two 1 gram capsules twice daily) for six months
Intervention: Lovaza™
Outcomes
Primary Outcomes
The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day
Time Frame: 6 month visit
The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (\~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.
Secondary Outcomes
- Modulation of the Risk Biomarker Masood Score(6 month value compared to baseline value)
- Modulation of Ki-67 Expression(6 month value compared to baseline value)
- Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.(baseline to end of intervention (~6 months))
- Change in Quality of Life.(duration of intervention, baseline to ~ 6 months)