
“I think it’s essential that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking to see if a type of fish oil, on its own or in combination with aspirin, can stop small growths on the bowel lining growing back after being removed. Doctors are keen to remove these small growths () because there is a risk that they may develop into bowel cancer.
At the moment, the standard way of finding polyps is by having a camera test of the large bowel, called a colonoscopy. If polyps are there, they can be removed at the same time. Removing bowel polyps reduces the future risk of bowel cancer, but it does not prevent all cases of bowel cancer.
Doctors want to find a better way to reduce bowel polyps and reduce cancer risk. One way is to treat people with drugs or food supplements after they have had polyps removed. This is called chemoprevention. Doctors also hope that it will reduce the number of colonoscopies each person needs, or possibly mean some people can stop having them altogether.
This trial is looking at a type of fish oil called eicosapentaenoic acid (EPA) and aspirin as a possible way of stopping polyps growing. We already know that fish oil can reduce the number and size of bowel polyps in people with a rare condition passed down in families. Doctors also think that taking daily aspirin helps prevent bowel polyps and bowel cancer, but they are not yet sure about the best dose, or who it would help most.
In this trial researchers want to test whether fewer polyps grow back when people who have had bowel polyps removed take fish oil alone or with aspirin.
You may be able to enter this trial if you
You cannot enter this trial if you
This trial is randomised. The people taking part are put into one of 4 groups randomly. Neither you nor your doctor will be able to decide or know which group you are in. People in
Whichever group you are in, you take 3 capsules every morning, 2 capsules in the afternoon or evening, and one tablet once a day. You take these with food.
Before you start the trial medication you fill out a short questionnaire so that the team can work out how much fish oil is in your normal diet. This questionnaire should take about 10 minutes to complete. You repeat it when you complete the course of trial medication.
You take part in this trial for 12 months. The person who carries out tests on your bowels (Bowel Screening Practitioner) or research nurse will contact you every few months during the trial to see how you are getting on.
You finish the trial when you have seen the Screening Practitioner after your follow up colonoscopy, which is 12 months after your first one. This second colonoscopy is a routine part of the bowel screening programme. The team may collect tissue samples (biopsies) during this second colonoscopy. You then continue in the bowel screening programme as normal.
The team will ask to study polyp tissue from your first colonoscopy and any polyps found from your second colonoscopy.
If you need to have any more colonoscopies as part of the programme, the team would like to look at the results, for up to 6 years after you left the trial. You do not have to agree to this if you don’t want to. You can still take part in the rest of the trial.
The trial is designed to fit in with your bowel cancer screening care. The only extra visit you will need to make is 6 months after you joined the trial. You will see the team at this visit and collect your second 6 months worth of trial medication. The team will pay any travel expenses for this visit, up to the cost of £10.
You will give a blood and urine sample for the study
Taking biopsies during your colonoscopy is a routine procedure and very safe. There is a possible risk of tearing the bowel wall (perforation) or serious bleeding, but this is a very small risk as the biopsies taken are very small.
Possible side effects from fish oil include
Possible side effects of using aspirin in this trial may include
Fish oil can slow blood clotting in a similar way to aspirin. Taking fish oil and aspirin together has not been tested in a clinical trial before. The team do not think there would be a problem, but to be on the safe side, they will ask you to stop the trial medication 10 days before your surgery, and not restart it until 4 days afterwards to prevent any possible risk of bleeding. They will also give you an information card to show your doctor or surgeon.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Hull
Clinical Trials Unit of the University of Nottingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Efficacy and Mechanism Evaluation (EME) Programme
University of Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s essential that people keep signing up to these type of trials to push research forward.”