RESOLVE
Research type
Research Study
Full title
RESOLVE: An open label, parallel arm, randomised controlled trial to assess the efficacy of Dropizol as a treatment for radiotherapy- and/or chemotherapy- induced severe diarrhoea in people with cancer
IRAS ID
1011453
Contact name
Stephen Deacon
Contact email
Sponsor organisation
Pharmanovia (Atnahs Pharma UK Ltd)
ISRCTN Number
ISRCTN71510134
Research summary
Many people with cancer develop severe diarrhoea during chemotherapy or radiotherapy treatment - affecting up to 80% of patients. This can be dangerous, causing dehydration and malnutrition, and may force doctors to pause vital cancer treatments. Often, loperamide is used as a treatment, but this doesn't always work well enough for many patients with severe diarrhoea.
This study will test if a medicine called Dropizol (made from opium) works better than loperamide for treating severe cancer treatment-related diarrhoea. The research will compare three approaches: Dropizol alone, loperamide alone, or both medicines together.
The study will involve 279 adults with cancer who develop severe diarrhoea during their cancer treatment. To take part, participants must be 18 or over, receiving chemotherapy and/or radiotherapy, and experiencing severe diarrhoea that hasn't responded well enough to initial loperamide treatment. The research will take place at NHS hospitals with specialist cancer (oncology) services across the UK.
For each participant, the study will last approximately 4 weeks. Everyone will first receive standard loperamide treatment for 12-36 hours. If this doesn't help enough, they will be randomly assigned to one of the three treatment groups for up to 5 days. Participants will complete regular questionnaires about their symptoms and quality of life, and will be monitored regularly by their healthcare team, either as inpatients or outpatients, depending on the severity of their symptoms.
The study is funded by Pharmanovia (the company that owns Dropizol) and is led by Dr Pablo Nenclares at Barts Cancer Centre in London. The results could help improve the treatment of this common and distressing side effect, potentially helping more patients complete their planned cancer therapy without interruption.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0013
Date of REC Opinion
3 Mar 2025
REC opinion
Further Information Favourable Opinion