COLO-PREVENT: A platform for developing COLOrectal cancer PREVENTion therapies
Research type
Research Study
Full title
COLO-PREVENT – A phase 2/3 randomised platform trial assessing the efficacy of aspirin, aspirin plus metformin, or resveratrol, for colorectal polyp prevention in patients undergoing surveillance in the Bowel Cancer Screening Programme
IRAS ID
1005142
Contact name
Anne Thomas
Contact email
Sponsor organisation
University of Leicester
Eudract number
2022-000531-23
ISRCTN Number
ISRCTN13526628
Research summary
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. 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.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0109
Date of REC Opinion
14 Jun 2022
REC opinion
Further Information Favourable Opinion