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.

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.

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.

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.

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.

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.

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.

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.