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ACTIVE NOT RECRUITING
NCT03428477
PHASE3

EPA for Metastasis Trial 2

Sponsor: Mark A Hull, PhD FRCP

View on ClinicalTrials.gov

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. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)

Official title: A Randomised Placebo-controlled Phase III Trial of the Effect of the Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA) on Colorectal Cancer Recurrence and Survival After Surgery for Resectable Liver Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2018-05-02

Completion Date

2026-04-30

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DRUG

Icosapent Ethyl

Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day

OTHER

Placebo

Composition: soft, amber to light yellow, oblong gelatin capsules containing light mineral oil: Dose: 4 capsules per day

Locations (13)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Royal Hampshire, United Kingdom

Aintree University Hospitals NHS Foundation Trust

Aintree, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Cambridge UniversityHospitals NHS Foundation Trust

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Leeds Teaching Hospitals NHS Foundation Trust

Leeds, United Kingdom

King's College London

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom