RecruitingInterventional

Feasibility study of the treatment of oral mucositis from radiotherapy

This study is exploring a common herbal extract to see if it can help prevent or ease mouth and throat soreness, called oral mucositis. This soreness is a tough side effect for people with head and neck cancer undergoing radiotherapy. Currently, treatments for oral mucositis aren't always widely available or fully effective, and they can cause pain and make eating difficult. This small "feasibility study" aims to gather information to help design a larger research project in the future. It wants to learn how well the herbal extract works, how safe it is, and if people are willing to take it. The goal is to find better, milder ways to reduce the discomfort and improve the lives of patients undergoing cancer treatment.

At a glance

Status

Recruiting

Sponsor

University of West London

Enrolment target

Start

02 Jan 2026

Estimated completion

30 Jun 2026

Prevention of oral mucositis in patients with head and neck cancer undergoing radiotherapy

What is this study about?

When you have cancer treatment like radiotherapy for head and neck cancer, a common side effect is a sore mouth and throat, known as oral mucositis. This can be really uncomfortable, making it hard to eat, drink, and even talk. It can also lead to pain, infections, and even weight loss, affecting your overall quality of life.

Currently, the ways we treat this soreness aren't always ideal. Some treatments aren't widely available, and others might need special equipment. This means there's a real need to find new, gentle, and effective ways to help people feel better during and after their cancer treatment. This study is looking at a commonly used herbal extract as a possible solution.

This isn't a large study yet; it's a 'feasibility study'. Think of it as a practice run to make sure everything is in place before a much bigger study. The main goal is to see if it's practical to conduct a larger study on this herbal extract in the UK, to check if people are willing to take part, and to gather early information on how safe and potentially helpful the herbal extract might be. The information from this small study will help scientists design a bigger, more thorough study in the future to find better treatments for oral mucositis.

Key takeaways

It's a small 'feasibility study' to test a new treatment for mouth sores from radiotherapy.
The study is looking at a common herbal extract.
It aims to find better ways to help people with head and neck cancer feel more comfortable.
Participation involves questionnaires and a phone interview.
You might receive the herbal extract or usual care, decided by chance.
The study aims to gather information for a larger study in the future.

Who may be eligible?

This study is for adults aged 18 or over who are having radiotherapy for head and neck cancer. You can be undergoing radiotherapy only, or radiotherapy combined with chemotherapy. You should also be at least two weeks past any surgery you might have had related to your cancer.

There are some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you already take turmeric supplements. You also can't participate if you're allergic to turmeric or can't swallow capsules. If you have any sores or problems in your mouth that aren't related to your cancer or its treatment, you also won't be able to join.

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 having radiotherapy for head and neck cancer?
Are you at least two weeks past any recent surgery?
Are you able to swallow capsules?
Are you NOT currently taking turmeric supplements?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, a computer will randomly place you into one of two groups, much like flipping a coin. One group will receive information about the study's herbal treatment, and the other group will receive the usual care if they develop mouth and throat soreness.

Regardless of which group you're in, you'll be asked to fill out four questionnaires three times: at the start of your treatment, weekly during treatment, and then again one, two, and three months after your treatment finishes. Each set of questionnaires will take about 25 minutes and will ask about your cancer symptoms and how you're feeling overall. You'll also be asked some general information about yourself, like your age, but you don't have to answer questions you're not comfortable with.

Everyone in the study will also be invited to have a phone chat once your treatment has started. This chat will last about 45 minutes and can be arranged at a time that suits you. It’s a chance for you to share your thoughts about the study, and if you're in the group receiving the herbal extract, to talk about your experiences with it. If you're in the group offered the study treatment, you'll get a separate consent form later to decide if you want to take the herbal extract.

Potential risks and benefits

A possible benefit of taking part is that the herbal extract might help reduce your mouth and throat soreness, potentially improving your comfort during and after cancer treatment. However, it's also possible that the study treatment might not be as effective as standard care, or it might not work at all. The herbal extract is generally considered safe, but there's a small chance of minor side effects like an upset stomach, headache, or feeling sleepy. More serious side effects are rare. The extract could also affect how thick your blood is or interact with other medications, which will be checked carefully before you join. You are always free to leave the study at any time, for any reason.

Locations (3)

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

University College London Hospitals NHS Foundation Trust
City only
London, United Kingdom
Guys and St Thomas' NHS Foundation Trust - Cov Boost Covid19 Trials
City only
London, United Kingdom
The Christie at North Manchester General Hospital
City only
Manchester, United Kingdom

Common questions

What is oral mucositis?

Oral mucositis is a common side effect of cancer treatment, like radiotherapy, which causes painful sores and inflammation in the mouth and throat.

What is the study investigating?

The study is looking into a commonly used herbal extract to see if it can help prevent or treat oral mucositis in people with head and neck cancer.

Where is the study taking place?

The study is based at University College Hospital, London, with other sites at Guy's and St Thomas' Hospital, London, and The Christie Hospital, Manchester, UK.

When will the study start?

The study is planned to begin in early 2026, and they expect to enroll participants for at least 6 months after that.

Who is paying for this study?

The study is being funded by The University College London Hospitals Charitable Trust, UK.

How to find out more

Saul Berkovitz

saul.berkovitz1@nhs.net +44 (0)7944922759 Official trial record

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