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.
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.
EMT2 trial update during the COVID-19 pandemic – Update December 2020
Thanks to the commitment of trial participants and research staff, the EMT2 trial remains open and is recruiting well. Some hospitals have needed to stop recruitment temporarily in the past few weeks due to pressure of COVID-19 work but follow-up of patients in the trial has continued unaffected. There is no suggestion that the active treatment in EMT2 (EPA) affects the body’s immune response to vaccines so we do not expect that participation in the EMT2 trial will affect any individual’s vaccination priority or response to it.
Sept 2020 – The trial has re-started really well since July with 20 patients recruited by seven sites. We are seeking ethical approval to allow telephone consent in case hospital visits before liver surgery are restricted in the coming months.