EMT2: EPA for Metastasis Trial 2
Research type
Research Study
Full 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
IRAS ID
199321
Contact name
Mark Hull
Contact email
Sponsor organisation
University of Leeds
Eudract number
2016-000628-24
Duration of Study in the UK
4 years, 8 months, 0 days
Research summary
A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to their liver (metastases) develop disease recurrence and die from their disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took naturally-occurring ‘omega-3’ EPA (a fish oil supplement) before their 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 EPA-triglyceride (purified from fish oil) or placebo (dummy capsules). EMT2 will investigate 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.
Participants will receive five capsules per day of either EPA or placebo and the allocation will be generated at random by a computer. This is a double blinded trial which means that neither the participant nor the clinician will know which treatment the participant is receiving during the trial. Trial treatment will start at least two weeks prior to liver surgery and will continue for at least two, and up to four years, after surgery. The trial will be open for at least two years after the last participant enters the trial so the length of treatment will depend on when the participant joins the trial.
The trial visit schedule closely mirrors the standard follow-up visits which are part of standard care. Participants are seen at least two weeks before liver surgery, at liver surgery and then at six-monthly intervals thereafter for a minimum of two years and a maximum of four years. Depending on when the participant last attended clinic at the time the trial closes, a trial-specific appointment at the end of the trial may be required.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0140
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion