CompletedPhase IVInterventional

RESOLVE: A research study investigating the effectiveness of a medicine called Dropizol for treating severe diarrhoea caused by cancer treatments

The RESOLVE study aims to find a better treatment for severe diarrhoea, a common and difficult side effect of chemotherapy and radiotherapy. Up to 80% of cancer patients experience this, and it can be dangerous, sometimes leading to pauses in vital cancer treatment. Currently, a medicine called loperamide is used, but it doesn't always work well enough. This study will test Dropizol, a medicine made from opium, alongside or instead of loperamide. Researchers want to see if Dropizol helps more effectively. About 279 adults with cancer and severe diarrhoea will take part, comparing three treatment approaches. The goal is to improve how this side effect is managed, helping more patients complete their cancer treatment without interruption.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

Pharmanovia (Atnahs Pharma UK Ltd)

Enrolment target

279

Start

01 May 2025

Estimated completion

01 Jun 2026

Severe diarrhoea

What is this study about?

When you're going through cancer treatment like chemotherapy or radiotherapy, severe diarrhoea can be a really challenging side effect. It affects a lot of people — sometimes as many as 8 out of 10. This isn't just uncomfortable; it can also be risky, leading to dehydration and making it harder for your body to get the nutrients it needs. Sometimes, it even means doctors have to temporarily stop your cancer treatment, which nobody wants.

At the moment, a medicine called loperamide is often used to treat this. However, for many people with severe diarrhoea, loperamide doesn't quite do the job. That's why the RESOLVE study is taking place. It's investigating whether a medicine called Dropizol, which comes from opium, might be a more effective option. The study plans to compare three different ways of treating severe diarrhoea: using Dropizol on its own, using loperamide on its own, or using both medicines together.

By comparing these different approaches, the researchers hope to find the best way to help people manage this difficult side effect. If Dropizol proves to be more effective, it could help many future patients feel better and complete their planned cancer treatments without having to take unwanted breaks. This research is important because it aims to improve the care and quality of life for people undergoing cancer treatment.

Key takeaways

This study is testing new ways to treat severe diarrhoea from cancer therapy.
It compares Dropizol (an opium-based medicine) with loperamide.
Participation lasts about 4 weeks and involves regular monitoring.
The goal is to help future cancer patients complete their treatment safely.
Common and rare side effects are possible with both medicines.

Who may be eligible?

The RESOLVE study is looking for adults aged 18 or over who are currently receiving chemotherapy, radiotherapy, or both. You might be able to take part if you're experiencing severe diarrhoea that has started because of your cancer treatment. This means your diarrhoea hasn't improved enough after trying loperamide, which is a standard medicine for this problem.

Diarrhoea is often considered severe in this study if it's very frequent or intense, or if it's causing other issues like increased risk due to your age or other health factors. Basically, if your diarrhoea is a significant problem and loperamide hasn't controlled it well enough, you might be a good fit for this important research. You'll also need to be able to give your consent and follow the study instructions.

It's important to know that if you are a woman who could become pregnant, or a man whose partner could become pregnant, you would need to agree to use effective contraception or avoid sex during the study and for a short time afterwards. This is a common and important safety measure in many medical studies.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently having chemotherapy, radiotherapy, or both?
Are you experiencing severe diarrhoea that started because of your cancer treatment?
Has standard loperamide treatment not fully helped your diarrhoea?
Do you have access to a smartphone, tablet, or laptop with internet?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the RESOLVE study, your involvement would last for about 4 weeks. Everyone will first be given the standard loperamide treatment for 12 to 36 hours. If your diarrhoea is still severe after this, you will then be randomly assigned to one of three groups for up to 5 days: one group will receive Dropizol alone, another will receive loperamide alone, and the third group will receive both medicines together.

Throughout the study, you'll be asked to fill out regular questionnaires about your symptoms and how your quality of life is affected. Your healthcare team will also monitor you closely. Depending on how severe your symptoms are, you might be an inpatient (staying in hospital) or an outpatient (visiting the hospital for appointments).

Potential risks and benefits

Taking part in this study may or may not directly benefit you personally. The main benefit is knowing that you are helping future patients receive better care for severe diarrhoea caused by cancer treatment, potentially allowing them to finish their vital therapies without interruption. However, like with any medicine, there are possible side effects. Common ones for loperamide include headache, constipation, sickness, and stomach wind. Common side effects for Dropizol include feeling sleepy, constipation, dry mouth, difficulty passing urine, dizziness, and headache. More serious, but rare, risks for both medicines include severe bowel problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
United Kingdom

Common questions

What is the main goal of this study?

The main goal is to find out if Dropizol, either alone or with loperamide, is a more effective treatment for severe diarrhoea caused by cancer treatments than loperamide alone.

How long will I be involved in the study?

If you participate, your involvement in the study will last for approximately 4 weeks.

What is Dropizol?

Dropizol is a medicine that comes from opium, and this study aims to see if it helps to treat severe diarrhoea linked to cancer treatments.

Will I know which treatment I'm receiving?

Yes, this is an "open label" study, meaning you and your doctors will know which treatment you are receiving.

Who is running this study?

The study is led by Dr. Pablo Nenclares at Barts Cancer Centre and is supported by Lindus Health, a research organisation, with funding from the company that owns Dropizol, Pharmanovia.

How to find out more

Alexandra Robbins

alex@lindushealth.com +44 800 058 4113 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.