"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."
A trial of aprepitant to reduce sickness caused by chemotherapy in children and young people
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called aprepitant to see if it helps to reduce sickness as a side effect of chemotherapy in children.
The trial includes children and young people up to and including the age of 17. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
A common side effect of chemotherapy is feeling or being sick. Doctors use various drugs to try to stop or reduce this type of sickness. Aprepitant is a drug that is used alongside other anti sickness drugs for adults. Researchers want to know if will also help children who are having chemotherapy.
The aims of the trial are 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 the drug in this age group
Who can enter
You may be able to enter this trial if you
- Have cancer and are at least 6 months old but under 18 years old
- Are about to start chemotherapy that can cause sickness – your doctors can advise you about this
- Are well enough to take part – if you are over 10 years old this means that you can mostly care for yourself (Karnofsky score of more than 60), for children under 10 it means that you are up and around, even if not playing as energetically as usual (Lansky score of more than 60)
- Have satisfactory blood test results
- Are willing to use a reliable form of contraception during the trial and for a month afterwards if you are sexually active and there is any chance you could become pregnant
You cannot enter this trial if you
- Have a brain tumour or cancer that has spread to your brain or spinal cord if this is making you feel sick or be sick
- Are sick for any other reason in the 24 hours before starting the trial treatment
- Are going to have a stem cell transplant after your chemotherapy
- Have radiotherapy to your tummy (abdomen) or pelvis in the week before starting the trial treatment or will be having radiotherapy during the trial
- Are known to be allergic to any of the drugs in the trial
- Take a drug called warfarin to thin your blood
- Have already taken part in a trial looking at aprepitant or a drug called fosaprepitant
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Start certain other drugs in the 2 or 3 days before the trial treatment – the trial team can advise you about this
- Have certain heart problems or take other medication that could affect your heart rhythm - the trial doctor can also advise you about this
- Have any other medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This phase 3 trial will recruit about 300 children and young people. There are 2 parts to the trial.
The first part of the trial is randomised. This means you are put into 1 of 2 treatment groups at random. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
During your first cycle of chemotherapy, you have either aprepitant or a dummy drug (
You take aprepitant (or the dummy drug) as a tablet once a day for 3 days. Children under the age of 12 have a powder form of the drug that you mix with water and then drink.
Everybody has other anti sickness drugs as well as aprepitant (or the dummy drug). This is
The trial team will ask you to fill in a diary for 6 days. In this, you note
- When you take the trial drugs
- How often you feel sick, or if you are sick
- If and when you need to take any extra anti sickness drugs
After you finish the first part of the trial, your doctor will ask you to join the 2nd part. You don’t have to join this part of the trial if you don’t want to.
If you do take part, you have aprepitant alongside the standard anti sickness drugs for up to 5 more cycles of chemotherapy. In this part of the trial, the researchers want to learn more about the side effects. Everybody has aprepitant – there is no dummy drug.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Heart trace (
You may be in hospital when you take the trial dugs. But if you are at home, a member of the trial team will contact you each day for 6 days to ask you questions about the diary you keep.
You see the trial team again between 6 and 8 days after starting the trial treatment. You have a physical examination, blood tests and another heart trace.
If you join the 2nd part of the trial, you see the trial team twice in each cycle of chemotherapy. You have extra blood tests, but you do not have to keep a diary.
The researchers want to learn more about the side effects of aprepitant in children and young people. In adults with cancer, the most common side effects of aprepitant are
- Tiredness (fatigue)
- Headache or dizziness
- Loss of appetite
- Constipation or diarrhoea
- Changes to the way your liver works
- Burping (belching)
Some people have had an allergic reaction to aprepitant causing a rash, itching and difficulty breathing or swallowing. If you have an allergic reaction, stop taking the drug and call your doctor straight away.
Rarely, it can cause a severe skin disease with rash, sores and skin peeling. This is called Stevens Johnson syndrome.
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.
Dr Julia Chisholm
Sharp & Dohme
NIHR Clinical Research Network: Cancer