EMT2 Clinical Trial
EMT2 – A double-blind randomised controlled trial of the omega-3 fatty
acid EPA in patients undergoing liver surgery for colorectal cancer liver
Metastasis
acid EPA in patients undergoing liver surgery for colorectal cancer liver
Metastasis
The results were presented at ESMO on Sunday Oct 25th and we are working
to update the website with trial results
OVERVIEW
Recruitment to the study has now closed. The patients will take
the capsules for the next 2 years so the results will be due in
2026.
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.
Participant Information Downloads
NEWS
STUDY TIMELINE
Recruitment to the study has now closed. The patients will take the
capsules for the next 2 years so the results will be due in 2026.
PARTNERS
Trial Funder
Trial Organiser
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
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
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.
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.
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.
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.
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.
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.
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.
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.
(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.
collected about you will be handled in accordance with the consent form
and the 1998 Data Protection Act.
RECRUITMENT
Patients Recruited
418
Recruitment closed on 30/11/2023.
RECRUITING CENTRES
The following hospitals sites are participating in the trial:
| Basingstoke & North Hampshire Hospital | Basingstoke |
| Churchill Hospital | Oxford |
| Queen Elizabeth Hospital | Birmingham |
| St James’s Hospital | Leeds |
| Queens Medical Centre | Nottingham |
| Northern General Hospital | Sheffield |
| Southampton General Hospital | Southampton |
| University Hospital Aintree | Liverpool |
| Freeman Hospital | Newcastle |
| Royal Free Hospital | London |
| Addenbrookes Hospital | Cambridge |
| King's College Hospital | London |
| University Hospital of Wales Hospital | Cardiff |
TRIAL TEAM
