NCT04216251

PRevention Using EPA Against coloREctal Cancer

PREPARE: PRevention Using EPA Against coloREctal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AMR101	AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-01-02
• Last updated: 2024-05-03
• Results posted: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study