A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Biomarker levels
研究概览
简要总结
Obesity promotes worse outcome for post-menopausal breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •At least 18 years of age
- •Post-menopausal as confirmed by 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/Ethics Committee
排除标准
- •Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease)
- •Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
- •Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
- •Known hypersensitivity to aspirin and/or omega-3 fatty acids
- •Actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation
- •Any aspirin or omega-3 free fatty acid supplementation within the last 14 days
- •Subjects who are pregnant
- •History of medical noncompliance
研究组 & 干预措施
Aspirin
Twenty eight enteric coated 81mg Aspirin tablets will be dispensed for daily oral dosing, to be taken with a meal at the same time of day.
干预措施: Aspirin (Drug)
Omega-3 Free Fatty Acids
Three hundred thirty-six gelatin coated 450 mg capsules containing approximately 180 mg of EPA and 135 mg of DHA will be dispensed. Patients are to take 12 capsules daily with meals, either once daily (12 capsules with one meal) or divided twice daily (e.g., six with breakfast and six with dinner).
干预措施: Omega 3 FFA (Dietary Supplement)
Aspirin & Omega-3 FFAs
Aspirin (81 mg po daily) to be taken simultaneously with Omega-3 Free Fatty Acids (1500mg of docosahexaoic acid (DHA) and 2500mg eicosapentanoic acid (EPA) given daily.
干预措施: Aspirin (Drug)
Aspirin & Omega-3 FFAs
Aspirin (81 mg po daily) to be taken simultaneously with Omega-3 Free Fatty Acids (1500mg of docosahexaoic acid (DHA) and 2500mg eicosapentanoic acid (EPA) given daily.
干预措施: Omega 3 FFA (Dietary Supplement)
结局指标
主要结局
Biomarker levels
时间窗: 29 days
Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment.
次要结局
- BMI(29 Days)
研究者
Andrew Brenner
Principal Investigator
The University of Texas Health Science Center at San Antonio