A trial looking at lowering the risk of hearing loss after cisplatin chemotherapy in children or young people with hepatoblastoma (SIOPEL 6)

Cancer type:

Children's cancers

Status:

Results

Phase:

Phase 3

This trial was done to find out if sodium thiosulphate can reduce high frequency hearing loss, which can be a side effect of cisplatin chemotherapy. It was for children and young people up to the age of 18 with hepatoblastoma that had not spread to another part of the body.

The trial was supported by Cancer Research UK.

More about this trial

Hepatoblastoma is a rare type of primary liver cancer that mainly affects young children. When it is contained within the liver and has not spread to another part of the body, doctors call it ‘standard risk disease’. They usually treat it with cisplatin chemotherapy and surgery.

All chemotherapy drugs have some side effects. One of the long term side effects of cisplatin is high frequency hearing loss. This means you may not be able to hear high pitched sounds. This can affect speech or learning in young children.

When this trial was done, research had already shown that giving sodium thiosulphate after cisplatin can lower the risk of hearing loss in adults. But researchers needed to find out if sodium thiosulphate works the same way in children and young people.

In this trial some children had cisplatin alone. And some had cisplatin and then sodium thiosulphate about 6 hours later. They all had 4 treatments and then an operation to remove the cancer. And then another 2 treatments, so 6 altogether.

The aim of this trial was to find out if giving sodium thiosulphate after cisplatin reduces the risk of high frequency hearing loss in children and young people.

Summary of results

This trial showed that sodium thiosulphate can help stop hearing loss in children and young people with hepatoblastoma.

The research team recruited people between 2007 and 2014, and published the results in 2018.

Results
This trial recruited over 100 children between 1 month and 8 years old, from 12 different countries. The children taking part were put into 1 of 2 groups at random:

  • 52 had cisplatin
  • 57 had cisplatin and sodium thiosulphate

The research team measured hearing levels before and after treatment in 101 children who took part. They found that there was at least mild hearing loss in:

  • 29 out of 46 children (63%) who had cisplatin
  • 18 out of 55 children (33%) who had cisplatin and sodium thiosulphate

Of these, there was marked or severe hearing loss in:

  • 6 out of 46 children (13%) who had cisplatin
  • 2 out of 55 children (4%) who had cisplatin and sodium thiosulphate

The researchers also looked at how well treatment worked in both groups. They wanted to make sure that adding sodium thiosulphate didn’t affect treatment. They found there wasn’t much difference between the 2 groups.

At the end of treatment, the cancer had gone away in:

  • 44 out of 52 children (85%) who had cisplatin
  • 52 out of 57 children (91%) who had cisplatin and sodium thiosulphate

When they looked at how many people were living 3 years after joining the trial, they found it was:

  • 48 out of 52 children (92%) who had cisplatin
  • 56 out of 57 children (98%) who had cisplatin and sodium thiosulphate

Side effects
Apart from hearing loss, some of the children in both groups had some other side effects. The most common side effects were:

  • a drop in white blood cells
  • infection
  • a drop in red blood cells

There is more information about cisplatin in our Cancer Drugs section.

Conclusion
The research team concluded that sodium thiosulphate could reduce hearing loss in children having cisplatin for hepatoblastoma. They also found that it didn’t affect how well treatment worked.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. 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 M. Ronghe

Supported by

Cancer Research UK
Cancer Research UK Children's Cancer Trials Team
University of Birmingham
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/07/023.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1107

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.”

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