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Contact Information:

Prof Karen Brown
-
kb20@leicester.ac.uk


Dr Anne Thomas
-
coloprevent@leicester.ac.uk


Study Location:

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Be Part of Research - Trial Details - COLO-PREVENT – do simple drugs (aspirin or aspirin plus metformin) or food supplements (resveratrol) reduce the occurrence of bowel polyps (small growths on the bowel lining), which in turn reduce bowel cancer risk?
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COLO-PREVENT – do simple drugs (aspirin or aspirin plus metformin) or food supplements (resveratrol) reduce the occurrence of bowel polyps (small growths on the bowel lining), which in turn reduce bowel cancer risk?

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Patients with high risk findings undergoing surveillance in the national Bowel Cancer Screening Programme

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


One way of preventing bowel cancer is to take drugs or dietary supplements (this is called therapeutic prevention). Most bowel cancers develop over many years from a polyp (a growth on the bowel wall). Several clinical studies have shown that aspirin use reduces the risk of developing polyps and the drug metformin, which is used in patients to treat diabetes, can also reduce the number of polyps. We want to test whether combining aspirin with metformin is able to prevent more bowel polyps forming than aspirin alone. We will test this in ‘high risk’ patients taking part in the national Bowel Cancer Screening Programme (BCSP), who have already had several polyps removed at the bowel camera test (colonoscopy). We are also keen to understand whether the dietary agent resveratrol which is found in red grapes, reduces the number of polyps formed. For this part of the study we will test two doses against a ‘dummy’ tablet in a way that both patients and medical staff do not know what treatment is being given. Patients already taking aspirin or metformin will be able to take part in the resveratrol sub-trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Sep 2022 31 Jan 2028

Trial drugs will be given for 3 years in the aspirin and metformin main trial and 12 months in the resveratrol sub-trial, until patients have another planned BCSP colonoscopy, at which time the number and size of polyps will be measured. We will collect blood, faeces, urine and tiny samples of rectal tissue (biopsies) so that we can learn more about how the therapies work, as well as develop ‘biomarker’ tests to predict who will or won’t respond to each therapy. We are particularly interested in examining the effects of the therapies on gut bacteria, which will be analysed using faecal samples. The expected benefit is that the therapies will reduce the number of polyps returning and therefore potentially the risk of developing a bowel cancer. A major advantage of metformin, aspirin and resveratrol is that they are safe, have few side-effects and are already widely used.


Patients aged 50-71 years (50-73 years in the resveratrol trial) with colorectal polyps.

You can take part if:



You may not be able to take part if:


General exclusion criteria for both trials:1. Malignant change in a polyp.2. Known clinical diagnosis or gene carrier of a hereditary CRC predisposition (FAP, hereditary nonpolyposis CRC).3. Previous or newly diagnosed inflammatory bowel disease.4. Previous or planned colorectal resection.5. Known bleeding diathesis or concomitant non-aspirin anti-coagulant or anti-platelet agent.6. Abnormal liver functions consisting of any of the following, at any time in the preceding 4 weeks:6.1. Serum bilirubin ≥1.5 x ULN (except for participants with Gilbert’s disease, for whom the upper limit of serum bilirubin is 51.3μmol/l or 3mg/dl)6.2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN 7. Inability to comply with trial procedures and use of therapies.8. Pregnant or lactating women. Women of child-bearing potential must agree to use appropriate methods of birth control (see protocol section 8.6)9. Males with partners who are WOCBP and are unwilling to use effective methods of contraception10. Serious medical illness interfering with trial participation including inability to have future colonoscopic surveillance.11. Participants who have been administered an investigational medicinal product for another research trial in the last 30 days or ≤5 elimination half-lives.

Exclusion criteria for the main trial but not the resveratrol Signal-Seeking trial:12. Regular (>3 doses per week) prescribed or ‘over the counter’ (OTC) aspirin or regular (>3 doses per week) prescribed or OTC non-aspirin NSAID use.13. Allergic or intolerant to ibuprofen or naproxen, metformin, aspirin or salicylate.14. Diabetic patients on drug treatment.15. Current or previous treatment with metformin16. Known history of peptic ulcer disease.17. Known history of lactic acidosis or predisposing conditions.18. Prior use of NSAIDs is not an exclusion if they are self-prescribed and the patient is willing to stop use for the duration of the trial.19. Use of long-term systemic corticosteroids

Additional exclusion criteria for the resveratrol Signal-Seeking trial only20. Unable to abstain from ingestion of OTC supplements containing resveratrol for the trial duration.21. Known yeast allergy22. Sensitivity or allergy to any of the capsule excipients


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Benefits:
There is no guarantee that individuals will personally benefit from taking part. All participants taking part in this trial will be helping to make a significant contribution to medical knowledge about preventing the formation of bowel polyps. This may help other patients in the future.
Risks:
Participation in a randomised controlled trial means that the participant and clinician are not able to choose all aspects of treatment and a careful explanation of the different treatments and toxicities by arm will be given to participants. The protocol has been designed to reflect the standard care pathway for patients on the Bowel Cancer Screening Programme (BCSP) with the minimal number of additional hospital visits and tests (over and above routine care) possible.
Use of low dose aspirin (75mg) will minimise the risk of adverse events; this is the lowest clinically used dose of aspirin in adults and is well tolerated.
To minimise the chances of Gastro Intestinal (GI) toxicity, patients randomised to metformin will start at a low dose of 500mg once daily and this will be increased after four weeks to the full dose of 500mg twice daily. Patients will be advised to take their tablets with or after food to help with treatment tolerance. If GI toxicities do occur this will be managed by dose reduction of metformin or a switch to a modified release (MR) preparation according to local policy.
For those who experience any rare side effects related to the study drugs and/or those who are unable to adhere to the protocol treatment schedule, active participation in the trial will end at this time. However, they will be asked if they wish to continue in the trial for collection of important outcome and safety data.
Blood sampling is required to answer trial objectives, and as per routine care some of these tests are required to be fasted. Usual clinical guidance will be followed and sites will be advised to book visits as early in the morning as possible. Potential patients will be given the opportunity to come back for a further visit if they are not happy to undergo the consent process in a fasted state. Although rectal biopsies are taken as part of routine care during colonoscopies, this type of sampling poses a theoretical risk of perforation or serious bleeding, though this is rare. Only a very small amount of tissue is required for the research rectal biopsies and will be obtained by trained physicians. Participants will be asked to consent to this separately and can still participate in the trial if they do not give their consent to this aspect of the trial.

Dr Anne Thomas
-
coloprevent@leicester.ac.uk


Prof Karen Brown
-
kb20@leicester.ac.uk



The study is sponsored by University of Leicester and funded by Cancer Research UK.



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Read full details for Trial ID: ISRCTN13526628

Or CPMS 53642

Last updated 29 October 2024

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