PRevention Using EPA Against coloREctal Cancer

Summary

Participation Requirements

Description

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 c...

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.

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