All studies
Active not recruitingPHASE3INTERVENTIONAL

EPA for Metastasis Trial 2

The EMT2 study is testing if a fish oil supplement called EPA can help people with bowel cancer that has spread to the liver. Many people who have surgery to remove these liver growths find the cancer comes back. A previous small study hinted that EPA might help, so this larger study aims to find out for sure. Participants will either be given EPA (Icosapent Ethyl) or a dummy capsule (placebo) before and for up to four years after their liver surgery. Doctors will then check if those taking EPA stay free of cancer recurrence for longer than those who took the dummy capsules. This research hopes to improve long-term outcomes for patients.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Mark A Hull, PhD FRCP
Enrolment target
418
Start
02 May 2018
Estimated completion
30 Apr 2026

What is this study about?

Bowel cancer is a common type of cancer, and sadly, it can sometimes spread to other parts of the body, most often the liver. When this happens, doctors often recommend surgery to remove these growths in the liver. While this surgery can be very effective, the cancer sometimes comes back. This is why researchers are always looking for new ways to help prevent this recurrence and improve recovery.

This study, called EMT2, is focusing on a special type of omega-3 fatty acid called EPA, which is found in fish oil. A smaller study in the past suggested that EPA might help some people whose bowel cancer had spread to their liver. Now, a larger study is needed to confirm if EPA truly makes a difference. The main goal of EMT2 is to see if taking EPA can help people stay free of cancer for longer after their liver surgery.

People taking part in the study will have their liver surgery as planned. However, before their surgery and for up to four years afterwards, they will take either the EPA supplement or a look-alike dummy capsule (placebo). This is a 'blinded' study, meaning neither the patient nor the doctors will know who is getting the real supplement and who is getting the dummy, ensuring unbiased results. The researchers will then carefully compare how long people in both groups stay free of cancer recurrence.

Key takeaways

  • Tests if a fish oil supplement (EPA) can stop bowel cancer spread from returning in the liver.
  • Aims to improve recovery and long-term outlook after liver surgery.
  • Participants will take either EPA or a dummy capsule for up to four years.
  • You won't know if you're taking the active supplement or the placebo.
  • Participation helps future patients, even if you receive the dummy capsule.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have received a diagnosis of bowel cancer that has spread to your liver. You must be planning to have surgery to remove these liver growths with the aim of curing the cancer. If you've had previous liver surgery for the current spread, you unfortunately can't join, but if this is a new spread needing surgery, you might be eligible.

You also can't join if you have cancer that has spread to other parts of your body that can't be treated, or if you're already regularly taking other omega-3 supplements or fish oil. People with certain allergies (like fish, soya, peanuts) or conditions (like certain bleeding disorders) are also not able to take part. Women who are pregnant or breastfeeding, or who could become pregnant and are not willing to use effective contraception, also cannot join.

It's important that you're able to follow the study's instructions and attend all follow-up appointments. If you've had other cancers in the last 5 years (apart from bowel cancer or very early-stage cancers like non-melanoma skin cancer that was completely removed), you also won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have bowel cancer that has spread to your liver?
  3. Are you planning to have surgery to remove these liver growths?
  4. Are you able to attend all planned hospital appointments?
  5. Do you currently avoid taking other fish oil or omega-3 supplements?
  6. Are you free from severe allergies to fish, soya, or peanuts?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the EPA supplement or a dummy capsule to take. You'll start taking these capsules before your planned liver surgery and continue for up to four years after your surgery. You'll have regular hospital visits and check-ups, just as you would normally for your cancer care, but there may be some additional assessments or questionnaires related to the study. The study doctors will monitor your health and any cancer recurrence carefully throughout this period.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. You might receive the active EPA supplement, which could potentially help prevent your cancer from returning, or you might receive the dummy capsule. Even if you receive the dummy capsule, the study helps advance medical knowledge that could benefit future patients. Potential risks from EPA are generally mild, such as stomach upset, but the study team will discuss all possible side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

  • Oxford University Hospital NHS Foundation Trust
    Verified postcode
    Oxford, United Kingdom
  • Hampshire Hospitals NHS Foundation Trust
    Verified postcode
    Basingstoke, United Kingdom
  • Aintree University Hospitals NHS Foundation Trust
    Verified postcode
    Aintree, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom
  • Cambridge UniversityHospitals NHS Foundation Trust
    Verified postcode
    Cambridge, United Kingdom
  • University Hospital of Wales
    Verified postcode
    Cardiff, United Kingdom
  • Leeds Teaching Hospitals NHS Foundation Trust
    Verified postcode
    Leeds, United Kingdom
  • King's College London
    Verified postcode
    London, United Kingdom
  • Royal Free London NHS Foundation Trust
    Verified postcode
    London, United Kingdom
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Verified postcode
    Newcastle, United Kingdom
  • Nottingham University Hospitals NHS Trust
    Verified postcode
    Nottingham, United Kingdom
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Verified postcode
    Sheffield, United Kingdom

Common questions

What is EPA?

EPA stands for eicosapentaenoic acid. It's a type of omega-3 fatty acid, like those found in fish oil, and is thought to have some anti-inflammatory properties.

What does 'placebo' mean?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the real treatment fairly.

Will I know if I'm getting EPA or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're taking the EPA supplement or the placebo until the study ends.

How long will I be taking the study capsules?

You will take the capsules before your liver surgery and for up to four years after surgery, or until your cancer recurs.

Can I take my usual medicines during the study?

The study team will review all your current medicines. You cannot take other omega-3 supplements, but most other medications are usually fine.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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