A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in circulating levels of eicosanoids.
研究概览
简要总结
Assess the impact of dietary omega 3 free fatty acids breast cancer patients.
详细描述
Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- •Consented for tissue collection on CTRC repository 07-32
排除标准
- •Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- •Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- •Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
- •History of medical noncompliance
- •Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
结局指标
主要结局
Change in circulating levels of eicosanoids.
时间窗: 30 days
Change in serum colony stimulating factor at surgery
时间窗: 30 days
Change in circulating levels of pro-inflammatory cytokines.
时间窗: 30 days
Change in circulating levels of metabolics.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Virginia G. Kaklamani
Principal Investigator
The University of Texas Health Science Center at San Antonio