OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colon Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blind, placebo-controlled, stratified, randomized clinical trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 oi...
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.
Tracking Information
- NCT #
- NCT03661047
- Collaborators
- Harvard School of Public Health
- Investigators
- Principal Investigator: Mingyang Song, MD, ScD Massachusetts General Hospital
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