Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lovaza™
Lovaza™ (two 1 gram capsules twice daily) for six months
干预措施: Lovaza™ (Drug)
结局指标
主要结局
The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day
时间窗: 6 month visit
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.
次要结局
- Modulation of the Risk Biomarker Masood Score(6 month value compared to baseline value)
- Change in Quality of Life(Change from Baseline to Month 6)
- Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma(Change from Baseline to Month 6)
- Change in Ki-67 Expression(6 month value compared to baseline value)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center