PRevention Using EPA Against coloREctal Cancer — PREPARE  

Colorectal Cancer Clinical Trial

Official title: PREPARE: PRevention Using EPA Against coloREctal Cancer

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Eicosapentaenoic Acid
• Endoscopic Surgery
• Gastrointestinal Microbiome

• NCT number: NCT04216251
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 9, 2020
• Completion date: September 30, 2022