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EPA for Metastasis Trial 2
Sponsor: Mark A Hull, PhD FRCP
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
Conditions
Interventions
Icosapent Ethyl
Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day
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