A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in levels of aromatase target gene.
研究概览
简要总结
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
详细描述
Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Postmenopausal as confirmed in medical history
- •Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB (Institutional Review Board)/Ethics Committee.
- •Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
- •Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32
排除标准
- •Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- •Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- •Any NSAIDs aspirin 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
研究组 & 干预措施
Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
干预措施: Letrozole (Drug)
Fish Oil
Fish oil 2700 mg by mouth daily for 30 days.
干预措施: Fish Oil (Dietary Supplement)
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
干预措施: Letrozole (Drug)
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Change in levels of aromatase target gene.
时间窗: 30 Days
Change in serum levels of PGE2 (prostaglandin E2).
时间窗: 30 Days
次要结局
未报告次要终点