A trial of aprepitant to reduce sickness caused by chemotherapy in children and young people

Cancer type:

Children's cancers

Status:

Results

Phase:

Phase 3

This trial wanted to see if giving aprepitant alongside other anti sickness drugs could help reduce sickness caused by chemotherapy.

More about this trial

A common side effect of chemotherapy is feeling or being sick. Ondansetron and dexamethasone are two drugs used to try to stop or reduce this type of sickness.

Aprepitant is an anti sickness drug that is already used alongside other anti sickness drugs for adults. Researchers wanted to know if aprepitant could also help children having chemotherapy.            

The main aims of this trial were to:

  • find out if aprepitant can reduce sickness caused by chemotherapy in children and young people under the age of 18
  • learn more about the side effects of aprepitant in children and young people

Summary of results

The trial team concluded that aprepitant together with ondansetron (and sometimes dexamethasone) can help children and young people having chemotherapy that is likely to make them feel or be very sick.

This was an international phase 3 trial. 307 children under the age of 18 took part.

Everyone had chemotherapy that is likely to make you feel or be very sick such as:

This was a randomised trial. Everyone was put into 1 of the following treatment groups by computer:

  • aprepitant
  • dummy drug (placebo Open a glossary item)

Neither they nor their doctor could choose which group they were in. And neither they nor their doctor knew which treatment they were having. This was a double blind trial.

The research team looked at the number of children that took part in each group:

  • 152 children had aprepitant
  • 150 children had the dummy drug

Trial Diagram

5 children didn’t have treatment with either aprepitant or the dummy drug.

The trial team looked at how well aprepitant worked. To do this they looked at the number of children who weren’t sick after chemotherapy. They found it was:

  • 77 out of 152 children (51%) in the aprepitant group
  • 39 out of 150 children (26%) in the dummy drug group

They also looked at the amount of time it took for children in both groups to be sick after chemotherapy. They found it was:

  • about 96 hours in the aprepitant group
  • about 27 hours in the dummy drug group

The trial team looked at the side effects from aprepitant or the dummy drug. They found that 5 out of 152 children (3%) in the aprepitant group had:

  • hiccups
  • infection with a bacteria called clostridium difficile
  • sickness (vomiting)
  • constipation
  • low levels of calcium and potassium in the blood
  • changes to how the heart works

3 out of 150 children (2%) in the dummy drug group had sickness and a high level of liver enzymes in the blood.

The study team concluded that aprepitant can help to reduce sickness caused by chemotherapy in children and young adults.

They also concluded that the number of children who benefit from having aprepitant is lower than the number of adults who benefit. They think this is because the combination of chemotherapy drugs used to treat children cause more sickness than the combinations of drugs commonly used to treat adults.

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 Julia Chisholm

Supported by

Merck Sharp & Dohme
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8878

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

Katie took part in a new clinical trial

A picture of Katie cycling

"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."

Last reviewed:

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