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

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:

• vincristine
• etoposide
• ifosfamide
• doxorubicin

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

• aprepitant
• dummy drug (placebo )

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

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 ) 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.