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Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases

NCT04682665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2024-12-04

No results posted yet for this study

Summary

A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. The EMT2 study (NCT03428477) is a clinical trial of the omega-3 fatty acid EPA, investigating whether patients who EPA ethyl ester remain free of disease recurrence for longer than those taking placebo. Recent data suggest that the anti-cancer effect of EPA may result from changes to the microbiota (gut bacteria) which lead to an improved anti-cancer response by the immune system. This study will collect biospecimens (stool, urine, blood, tumour tissue) from participants in the EMT2 trial in order to interrogate the microbiome and immune mechanisms associated with EPA treatment, in relation to participant survival. Insights from this study will identify those most likely to benefit from treatment, leading to more targeted, personalised use of EPA.

Conditions

  • Colon Cancer Liver Metastasis

Interventions

DRUG

Icosapent Ethyl Oral Capsule

Soft gelatin capsules containing 1g pure EPA-EE. Administered as 4g per day to be taken as 2 capsules in the morning and 2 capsules in the evening.

OTHER

Placebo

Soft gelatin capsules containing light mineral oil. 4 capsules to be taken per day (2 in the morning and 2 in the evening).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Massachusetts Institute of Technology

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • University of Bradford

    collaborator OTHER

  • University of Leeds

    lead OTHER

Principal Investigators

  • Mark Hull · University of Leeds

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682665 on ClinicalTrials.gov