EMT2 – A double-blind randomised controlled trial of the omega-3 fatty acid EPA in patients undergoing liver surgery for colorectal cancer liver Metastasis

OVERVIEW

This clinical trial has been designed to test whether a naturally-occurring omega-3 fatty acid called eicosapentaenoic acid (EPA for short) improves outcomes in patients who have an operation for the removal of bowel (also known as colorectal) cancer that has spread to the liver.

A small trial in Leeds suggested that a high-purity, high-dose preparation of EPA might be beneficial but only a bigger trial can give us a definite answer as to whether taking EPA will work. The EPA capsules are being compared with dummy (placebo) capsules so that we can be sure that EPA is or isn’t better than no supplement at all.

Taking part involves starting trial capsules before the operation and then continuing them after surgery even if the bowel cancer comes back. There are trial visits every 6 months that can either be combined with outpatient clinic visits or by telephone, if the hospital is a long way away.

Trial tests include the check-up CT scans that would be performed by the hospital department anyway, but also questionnaires about quality of life and some patients will be asked for extra blood tests.

NEWS

EPA CAPSULES USED IN EMT2 RECEIVE A LICENCE FOR USE FOR PREVENTION OF HEART DISEASE IN THE UK

Update JULY 2021

The EPA capsules used in the EMT2 trial have now received approval from the MHRA (the drugs approvals agency in the UK) for use for prevention of cardiovascular (heart) disease in people with risk factors for heart disease (the medicine is called Vazkepa). As part of the licensing process, the MHRA wanted the Patient Information Leaflet to explicitly mention that the capsule coating contains small amounts of a substance called soya lecithin and that people with a known soya or peanut allergy should avoid the capsules

As a result of this new information the EMT2 trial team have now changed the trial patient information sheet to make sure that anyone with a known soya or peanut allergy, or a rare hereditary condition called hereditary fructose intolerance, does not join the trial. Please note that the capsules used in the trial have not changed and have always contained the same substances.

The trial team have also updated the information sheet to point out a small risk of irregular heart rate called atrial fibrillation that has recently been associated with EPA treatment and also a small increase in bleeding risk seen in a clinical trial of Vazkepa for those patients who already take anti-coagulant medication like warfarin. Neither of these new findings has altered how the trial is conducted.

People who are already in the trial and have been taking the capsules already without any allergy problem will need to read an updated information sheet and will be contacted via telephone by their local research team in order to provide written informed consent again. The local research team will be able to answer any questions that you may have about this news item or other aspects of the EMT2 trial.

@EMT2study Twitter Feed

STUDY TIMELINE

EMT2 is open for recruitment. The first patient was recruited in May 2018 and the patients are expected to be invited to join until the end of 2021. The last patients to join will take the capsules for at least 2 years so the results will be due in 2024.

PARTNERS

Trial Funder

Trial Organiser
Clinical Trial Research Unit
Trial Review and Approvals
The trial has been approved by a Research Ethics Committee, Health Research Authority and the Medicines & Healthcare Regulatory Authority who oversee all drug trials in the UK

FREQUENTLY ASKED QUESTIONS

WILL MY CANCER TREATMENT BE ALTERED BY JOINING THE TRIAL?

Your standard of treatment and care will not be affected by either volunteering or not taking part in the trial. Always remember that you can withdraw from the trial at any point, without giving a reason.

WHAT IS EPA?

EPA is one of the main omega-3 fatty acids found naturally in oily fish like sardines and mackerel, along with another fatty acid called DHA. DHA is thought to be important for brain and nerve development and function, whereas EPA has anti-inflammatory effects. The best evidence that omega-3s have anti-cancer activity is for EPA, which is why we are testing EPA on its own in EMT2.

WHAT ARE THE CAPSULES BEING USED IN EMT2?

The EPA capsules in EMT2 are pure EPA and give a high dose of EPA. The same capsules and dose of EPA has recently been shown to reduce risk of heart attack and stroke in individuals at high risk of such events in an international trial. The capsules (EPA and placebo capsules) are provided by Amarin Corp. and are called Vascepa®, which is already licensed for use in people with high blood lipid levels in the USA. The EPA is derived from fish and the capsule contains gelatin from an animal source so the trial is not suitable for Vegetarians.

WHY NOT TAKE AN OMEGA-3 CAPSULE AVAILABLE FROM THE SHOPS OR ONLINE?

Omega-3 capsules available on the high street contain a much lower dose of EPA than the trial capsules (approximately three times less EPA than a Vascepa® capsule). The fatty acid content in high street capsules is a complex mix of the multiple fatty acids found in fish oil, including some omega-6 fatty acids, the effects on cancer of which are unknown. We stipulate that no other omega-3 fatty acid supplements should be taken during the trial.

DOES EPA CAUSE ANY SIDE-EFFECTS?

Some people may experience some mild side effects relating to their digestive system such as nausea and diarrhoea, but these often can be minimised if the capsules are taken with meals.

HOW MANY TRIAL VISITS ARE THERE?

There will be regular contact by either telephone or study appointments (maybe 5-10), which will link to your standard care appointments, wherever possible. If transport is a problem then telephone follow-up can be done and capsules posted by Courier.
These visits will include a review of your progress, a health questionnaire, a prescription for new capsules and, for some participants, a blood test.

IS ALL MY TRIAL INFORMATION CONFIDENTIAL?

Confidentiality during the trial is important, and the information collected about you will be handled in accordance with the consent form and the 1998 Data Protection Act.

RECRUITMENT

Patients Recruited

298
As of Monday 16/05/2022

Target

448

RECRUITING CENTRES

The following hospitals sites are participating in the trial:
Basingstoke & North Hampshire HospitalBasingstoke
Queen Elizabeth HospitalBirmingham
St James’s HospitalLeeds
Queens Medical CentreNottingham
Northern General HospitalSheffield
Southampton General HospitalSouthampton
University Hospital AintreeLiverpool
Freeman HospitalNewcastle
Royal Free HospitalLondon
Addenbrookes HospitalCambridge
King's College HospitalLondon
University Hospital of Wales HospitalCardiff

TRIAL TEAM

Professor Mark Hull, Chief Investigator. Cath Moriarty, EMT2 Lead Research Nurse. Sharon Ruddock, Trial Manager.
Simone Ryan, Data Manager. Nicole (Pei-Loo) Ow, Trial Statistician. Alex Smith, Trial Delivery Lead.