Ondansetron for Low Anterior Resection Syndrome (OARS)
Research type
Research Study
Full title
Ondansetron for low anterior resection syndrome (OARS) after rectal cancer treatment: a multicentre randomised blinded placebo-controlled parallel group trial investigating the efficacy of ondansetron on symptoms
IRAS ID
264493
Contact name
Maura Corsetti
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Eudract number
2020-004560-25
ISRCTN Number
ISRCTN48772765
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Rectal cancer is one of the most common cancers in the UK, and although chemo-radiotherapy and surgery are effective treatments, up to half of all patients report severe distressing problems after their treatment has finished. These include diarrhoea and problems with bowel control, ranging from needing to rush to the toilet (urgency), to complete bowel incontinence. This range of symptoms is known as “Low Anterior Resection Syndrome” (LARS) and can significantly affect quality of life. Unfortunately, at the moment, there are no effective treatments for LARS.
The symptoms of urgency and diarrhoea reported by LARS patients are similar to those in Irritable Bowel Syndrome (IBS). In IBS it has been shown that a cheap, widely available drug, called ondansetron, normally used to treat nausea and vomiting, is effective and safe in treating diarrhoea and urgency. This leads us to believe that ondansetron could be effective in LARS.The aim of this study is to find out if ondansetron helps resolve LARS symptoms.
Half of the participants will receive ondansetron and the other half will receive a placebo (this will look exactly the same as ondansetron but with no active ingredient). The treatment a participant gets will be selected at random through a computer program and neither the researchers nor the participants will know which capsules they are getting.
Patients with LARS symptoms will be recruited from hospitals in England, at least 1 year after completion of all treatments for their rectal cancer. They will take ondansetron or placebo orally for 6 weeks, and complete a daily diary to record details on urgency, frequency and consistency of their bowel movements, and medication taken. Participants will also complete questionnaires about their bowel symptoms and quality of life, at the beginning and end of the trial.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0015
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion