PRevention Using EPA Against coloREctal Cancer

Status Not yet recruiting

Clinical Trial Summary

Within the gastroenterology practice of Massachusetts General Hospital (MGH), the investigators will conduct a prospective, single-arm clinical trial to measure the effects of daily 4-gram eicosapentaenoic acid (EPA), through treatment with AMR101 (VASCEPA, icosapent ethyl) on stool and tissue biomarkers associated with colorectal cancer.

Clinical Trial Description

This study will investigate the effects of standard-dose EPA treatment using the FDA-approved drug AMR101. AMR101 (icosapent ethyl) is a prescription medicine for adults to lower blood levels of triglycerides. It is supplied as a liquid-filled gel capsule for oral administration. The standard dose is 4 g per day (administered as 4 one-gram capsules). Each 1-gram capsule of AMR101 contains 1 gram of icosapent ethyl, which is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).

EPA possesses triglyceride-lowering and anti-inflammatory activities, and has been suggested to be beneficial for a variety of health outcomes in adults, including coronary heart disease, stroke, type 2 diabetes,depression, and inflammatory bowel disease, although the data are not univocal. Increasing evidence supports the anticancer effect of EPA.

Colorectal cancer is the third leading cause of cancer-related deaths in the US. Substantial data support the benefit of EPA for colorectal cancer prevention and treatment, which may be mainly due to the immunomodulatory and anti-inflammatory activity of EPA. Increasing data support that gut microbes are pivotal in integrating dietary cues with host immunity, and that disturbances in the gut microbiota may promote colorectal cancer by breakdown of intestinal immune homeostasis. Dietary fat composition is a major driver of the gut microbial community structure and EPA has been shown to enrich the gut bacteria that possess immunoprotective activities. These data together the investigator's hypothesis that EPA modulates the gut microbiota to preserve colorectalic immune homeostasis and suppress colorectal cancer. In the current study, the investigators propose to experimentally test this hypothesis by assessing the effect of EPA supplement on the gut microbiota - host immune interaction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04172636
Study type	Interventional
Source	Harvard Medical School
Contact	Mingyang Song, MD, ScD
Phone	6174321301
Email	mis911@mail.harvard.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	March 1, 2020
Completion date	October 31, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PRevention Using EPA Against coloREctal Cancer — PREPARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms