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EMT2 News

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

NEWS

FAQ – Now that I have finished the trial capsules treatment, is there an alternative that I can take?

Until the EMT2 trial results are evaluated and published, there is no evidence that taking EPA is beneficial to patients who have had surgery for bowel cancer spread to liver. In the EMT2 trial, patients took a specific, high-dose form of EPA and therefore the study results (beneficial or otherwise) cannot be assumed to be similar for other omega-3 preparations with a different dose or level of purity.

By way of comparison, the daily dose of pure EPA in the trial was 4 x 1000 milligram capsules compared with typical omega-3 capsules available in Health Food outlets, which usually contain 200 milligrams EPA per capsule, and which include a mixture of other substances.

Overall, it is not recommended to take an alternative EPA or other omega-3 preparation to replace the trial treatment until the EMT2 trial results are available.

As soon as we can, we will describe the results of the trial in Plain English to you and family members, if you wish to know.

One year to go……………..behind the scenes in the EMT2 trial

This time next year, we will be preparing to stop the trial and analyse the results. We hope to be able to share the results with trial participants and trial staff a few months later in 2026. In the meantime, we are as busy as ever making sure that all the information that we have collected from participants during the trial is ready for immediate analysis in Leeds as soon as the last patients have stopped taking capsules.

A big ‘thank you’ to all participants who also provided samples that will enable us to investigate how EPA treatment is working. We are looking to see whether the gut bacteria that live naturally in the bowel make a difference to the effectiveness of EPA. Samples have been transferred to Boston in the USA and the experiments have started in the Harvard laboratory.

As ever, the Leeds team extend their heartfelt gratitude to all patients and research staff for their support and commitment to the EMT2 trial.

The EMT2 trial is now closed to recruitment of new patients

Although the trial closed to recruitment of new patients at the end of November 2023, the trial continues as normal with many patients still taking trial capsules for another two years. Thank you to all past and present participants, as well as the hard-working research teams at 13 hospitals in England & Wales, for ongoing commitment to the trial. By the end of November 2025, all patients will have stopped trial capsules and the trial team in Leeds will analyse the results, which should be publicly available by mid-2026.

Measuring ‘Quality of Life’ in the EMT2 trial

Capturing measures of quality of life by completing questionnaires about general health, well-being and daily activities is commonly carried out in clinical trials. More than one type of questionnaire is usually used to make sure that as many facets of daily living and well-being are covered as possible. In the EMT2 trial, we are testing whether taking EPA capsules improves quality of life, in addition to whether it lengthens survival after liver surgery. For that reason, we are grateful for the time you give to complete the questionnaires and submit them to the research team. Analysing changes in quality of life is a really important part of the trial and will help us gain maximum information about whether EPA should be used in patients with bowel cancer liver spread.

The EMT2 trial closes to recruitment at the end of November 2023

At the end of November 2023, the last patients will be recruited to the EMT2 trial. Two years after that, we will then be able to analyse the results and report whether EPA treatment has beneficial effects for patients after bowel cancer liver metastasis surgery. We expect to share the results with everyone in mid-2026. The trial team will post the results on the website and ensure that hospital teams have a summary of results to share with all participants and their families, on request.

In the meantime, a huge ‘thank you’ to all patients and research staff at the thirteen participating hospitals in England and Wales for making this trial possible. Trials like EMT2 are the only way to know for sure whether a treatment works and the Leeds team appreciate the commitment shown by all, especially in times of uncertainty during the COVID-19 pandemic.

We recently introduced a slight change to the way the trial works so that now we ask patients, who have got to the end of the maximum treatment period (four years), whether we can continue to look at hospital records after trial treatment is stopped until the end of the trial in November 2025. This will help ensure that we have the biggest chance possible to obtain a definitive result from the trial.

Thank you once again to everyone who has participated in and supported EMT2 – the trial team are most grateful.

EPA formulation used in the EMT2 trial gets NICE approval for prevention of heart attacks and strokes

The formulation and dose of the omega-3 EPA (icosapent ethyl) that is being tested in the EMT2 trial was approved by NICE in July 2022 for prevention of heart attacks and strokes in patients who already have cardiovascular disease or diabetes, and are already taking a statin drug but still have high levels of triglycerides. It is marketed as Vazkepa by Amarin Corp, which supplies the active and placebo forms of icosapent ethyl for the EMT2 trial.