This prospective, single-arm, research study evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.~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, including:~Lifestyle questionnaire,~Nutritional survey~Flexible sigmoidoscopy (24 biopsies of normal colorectal mucosa, one stool sample)~Blood samples,~AMR101 administered daily, orally for 8-12 weeks and it is expected 80 participants will take part.
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma.~- The name of the study drug involved in this study is:~-- AMR101 (VASCEPA).