Hundreds of people have now been recruited to a pioneering bowel cancer clinical trial funded by Yorkshire Cancer Research.
The £1.5m trial aims to find out if taking an omega-3 fatty acid naturally found in fish called EPA can help prevent bowel cancer from coming back after surgery.
Patients who are undergoing surgery for bowel cancer that has spread to the liver are taking part in the study, which is being led by Professor Mark Hull at the University of Leeds’s Institute of Biomedical & Clinical Sciences, St James’s University Hospital, and is run at the Clinical Trials Research Unit at the University of Leeds.
Announced on International Clinical Trials Awareness Day, which takes place on Friday, 20th May, the research team has now successfully recruited 300 patients to the study. A further 148 people will be recruited during the course of the trial.
Professor Hull said: “Reaching this key milestone is a huge achievement for this important clinical trial, especially considering the challenging circumstances we’ve experienced during the Covid-19 pandemic.
“Results from the trial should answer the question about whether EPA, which is a safe, natural product, is beneficial to advanced bowel cancer patients. It could lead to rapid introduction into the clinic, so it’s vital that people take part. We’d like to thank everyone who has signed up so far.”
Those taking part in the trial are given a high dose of a highly purified form of EPA to see if long-term treatment improves survival. Some participants are given dummy capsules, known as placebos, with no active ingredient in order to accurately compare the effect of the EPA.
People taking part in the trial also have the chance to join a related study funded by the American National Institutes of Health. Those who agree are asked to provide a stool sample which is analysed to see if people taking EPA have more healthy gut bacteria than people taking the placebo. This will help the researchers understand if healthy gut bacteria are the reason why EPA may have beneficial effects for advanced bowel cancer patients.
The EPA formulation, known as icosapent ethyl and marketed as Vascepa® in the United States, and the placebo, have been donated free of charge by Amarin Pharma Inc.
The study follows earlier investigations funded by Yorkshire Cancer Research, which tested the effect of EPA on cancer cells in the laboratory. The team also conducted a small, preliminary trial, which suggested some survival benefit. If successful, the trial could lead to use of EPA therapy, which is safe and has few side effects, in the clinic.
Using medicines to prevent cancer, a strategy called ‘chemoprevention’ or ‘therapeutic cancer prevention’, is a rapidly emerging way of reducing disease development. Using nutritional supplements like omega-3 or well-known drugs like aspirin is a promising area of research because they are safe to use with few side effects and are likely to be highly cost-effective.
Dr Kathryn Scott, Chief Executive at Yorkshire Cancer Research, said:
“This is a cheap and potentially powerful new way to help treat bowel cancer which, if successful, could have a huge impact. As well as having a potential impact on treatment and survival, the trial is providing an opportunity for patients across Yorkshire to take part in a pioneering study.”