NCT01252290

Breast Cancer Risk Biomarkers in Postmenopausal Women

Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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 postmenopausal women.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Lovaza™	4 capsules daily for 6 months

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-12-02
• Last updated: 2016-12-16
• Results posted: 2016-12-16

Locations

1 site across 1 country: United States