A trial of buprenorphine patches for children and young people who have mouth pain caused by chemotherapy (BUP1501)

Cancer type:

Children's cancers




Phase 1

This trial looked at a painkiller called buprenorphine for children and young people who had a sore mouth as a side effect of chemotherapy.

This trial was for children and young people up to the age of 16. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Chemotherapy Open a glossary item can cause temporary changes in the lining of your mouth and make it very sore. Doctors call this mucositis Open a glossary item. It can be very painful and you may need strong painkillers called opioids.

Researchers looked at an opioid drug called buprenorphine. In this trial it was in a patch that you put on your skin like a plaster. The patch released the drug into your body.

Buprenorphine is already used in adults, but researchers wanted to find out if it was safe for children and young people to have.

The aim of the trial was to learn more about what happens to buprenorphine in your body (pharmacokinetics Open a glossary item) and whether it helped to control mouth pain caused by chemotherapy.

Summary of results

The trial team found more about what happens to buprenorphine in children’s bodies in different weight groups.

This phase 1 trial closed early because recruitment was slow. The trial team intended to recruit 60 children. At the time the trial closed 25 children had joined. They were put into 1 of 2 groups according to their weight.

  • 18 children weighed 25 kilograms or more
  • 7 children weighed less than 25 kilograms

The researchers took blood samples to find out how much buprenorphine the children’s bodies absorbed.

When the researchers looked at the blood samples (pharmacokinetics) from the children they found that there was more buprenorphine in the blood of children who weighed more than 25 kg. The children in this group also had a patch that contained a higher dose of the drug. The amount of buprenorphine in their blood wasn’t higher than the blood samples of adults from a previous study.

So the researchers say that this study suggests that the amount of buprenorphine in the children’s blood from the patch wouldn’t be significantly different from what would be expected from adults who used the patch.

The most common reported side effects were diarrhoea and being sick. These are common side effects of drugs like Buprenorphine.

The trial team stated that due to the low numbers recruited and the difference in the patient numbers between the 2 groups it was difficult to compare the results and make meaningful conclusions.   

We have based this summary on information from the team who ran the trial.  As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Richard Hain

Supported by

Mundipharma Research Ltd
NIHR Medicines for Children Research Network (MCRN)

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Last review date

CRUK internal database number:

Oracle 8941

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

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