OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change in the marine omega-3 polyunsaturated fatty acid (MO3PUFA) composition in colorectal tissues as a result of the AMR101 treatment for up to 30 days.
研究概览
简要总结
This is a prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl) on the tumor immune microenvironment and gut microbiome in patients who are diagnosed with colorectal cancer or with a colorectal mass or polyp suspected to be a cancer or advanced adenoma and will undergo surgical resection or interventional endoscopy at the Massachusetts General Hospital (MGH). It uses the novel "window-of-opportunity" clinical trial design to take advantage of the window of time between cancer/mass/polyp diagnosis and surgery to examine the effect of therapeutic agents on tumor pathologic and molecular features unperturbed by prior therapies.
详细描述
This research study is evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal cancer, colorectal mass or polyp(s).
AMR101 is made of marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body.
The U.S. Food and Drug Administration (FDA) has not approved AMR101 as a treatment for any disease. AMR101 is commercially available in the US as VASCEPA (icosapent ethyl).
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits during which participants will complete a lifestyle questionnaire and a nutritional survey. A drug diary will be provided to be completed. Measurements will be taken, and blood and stool specimens will be collected. Tumor, colorectal mass, or polyp tissue will be collected for research purposes at the time of surgery or interventional endoscopy.
AMR101 administered daily, orally for up to 30 days and it is expected that 36 participants will take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omega-3 treatment
Daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl)
干预措施: AMR101 (VASCEPA, icosapent ethyl) (Drug)
Placebo
Identical placebo
干预措施: AMR101 (VASCEPA, icosapent ethyl) (Drug)
结局指标
主要结局
The change in the marine omega-3 polyunsaturated fatty acid (MO3PUFA) composition in colorectal tissues as a result of the AMR101 treatment for up to 30 days.
时间窗: An average of 2 years after study completion
The effect of daily 4-gram AMR101 treatment on MO3PUFA composition in colorectal tissue will be measured through the extraction of fatty acid with gas chromatography-mass spectrometry from the biopsy tissue.
次要结局
- The change in protein levels of IL10 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of LAG-3 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of TIGIT in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of TIM-3 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of PD-1 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in Tumor CD8+ T cells in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in gene expression profile of colorectal tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of FOXP3 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of CD49b in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of CTLA-4 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in protein levels of PD-L1 in the tumor tissue between pre- and post- AMR101 treatment period.(An average of 2 years after study completion)
- The change in the gut microbiome composition and function between pre- and post- AMR101 treatment period(An average of 2 years after study completion)
研究者
Andrew T. Chan, MD, MPH
Prinicipal Investigator
Massachusetts General Hospital