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A trial looking at lowering the risk of hearing loss after cisplatin chemotherapy in children or young people with hepatoblastoma (SIOPEL 6)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out if a drug called sodium thiosulphate can reduce high frequency hearing loss, which can be a side effect of cisplatin chemotherapy. It is looking at children or young people who need treatment for hepatoblastoma that has not spread to another part of the body. This trial is supported by Cancer Research UK.
This trial is for children and young people up to the age of 18. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
Hepatoblastoma is a rare type of primary liver cancer that mainly affects young children. When hepatoblastoma 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 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 may affect speech or learning in young children. Doctors do not know yet why it affects some children more than others, but it may be due to
Research in adults has shown that giving sodium thiosulphate after cisplatin can lower the risk of hearing loss. But researchers need to find out if sodium thiosulphate works the same way in children and young people.
The aims of this trial are to
- Find out if giving sodium thiosulphate with cisplatin chemotherapy reduces the risk of high frequency hearing loss in children and young people
- Learn more about hepatoblastoma and understand why some children treated with cisplatin are more likely to have hearing loss than others
Who can enter
You can enter this trial if you
- Have been diagnosed in the last couple of weeks with hepatoblastoma that is completely within the liver (standard risk disease)
- Are due to have cisplatin chemotherapy
- Are at least 1 month old, but no more than 18 years old
- Are prepared to use reliable contraception while taking part in the trial, if there is any chance that you or your partner could become pregnant
You cannot enter this trial if
- You have hepatoblastoma that has spread (high risk disease), or has come back after treatment
- You have a type of primary liver cancer called hepatocellular carcinoma (HCC)
- Your kidneys are not working as well as they should
- You have had chemotherapy before
- You are allergic to sodium thiosulphate
- You are pregnant
This is a phase 3 trial and will recruit 115 patients worldwide. The trial is randomised. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part will have cisplatin once every 2 weeks. This 2 week period is called a cycle of treatment. You have the drug over about 6 hours, through a drip into a vein. You will have extra fluid going through the drip at the same time. This will start 3 hours before you have the cisplatin and will continue for 24 hours after the cisplatin finishes. Then you have no treatment for the next fortnight.
You will have 4 cycles of cisplatin (over 8 weeks), before your operation. You will have another 2 cycles (over 4 weeks) after your operation.
If you are in group 2 you will have sodium thiosulphate 6 hours after each dose of cisplatin. You have this drug through the drip. It will take about 15 minutes.
The researchers will ask you if they can take samples of your cancer. If you agree, a doctor will take a sample when you have your biopsy and during the operation to remove your cancer. They will also ask for a small sample of blood. This is so they can learn about how the drugs work with each other in the blood and how your genes may affect this. If you don’t want to give these samples, you don’t have to. You can still take part in the trial.
You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include
- Physical examination
- Blood tests
- Tests to see how well the kidneys are working (kidney function tests)
- Hearing test
- Heart scan (echocardiogram)
- Either CT scan, MRI scan or X-ray
You will have these tests again before your operation and after your treatment. You will have blood tests and a physical examination before each cycle of chemotherapy.
Before you start your treatment your doctor may recommend that you have a central line put in. This makes it easier to give chemotherapy and to take blood samples. This may mean staying in hospital overnight.
You will be in hospital for one or two nights for each cycle of chemotherapy.
You may have a hearing test after every two cycles of cisplatin. You will have a further hearing test 6 to 12 weeks after treatment has finished. Young children will have this further test once they are 3½ years old. You may need to travel to another hospital for the hearing tests.
After your treatment has finished, you will see your doctor every 2 to 3 months for the first 2 years, and every 6 months for the next 3 years.
All drugs have side effects. The side effects for sodium thiosulphate are
- Feeling or being sick
- A temporary increase in blood pressure and sodium levels in the blood. You will have these checked during and after treatment
The most common side effects for cisplatin chemotherapy are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Hair loss
- Possible kidney damage (you will have plenty of fluid to prevent this from happening)
- Reduced hearing of high pitched sounds
There is more information about the particular side effects of cisplatin on this website.
How to join a clinical trial
Dr M. Ronghe
Cancer Research UK
Cancer Research UK Children's Cancer Trials Team
University of Birmingham
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/07/023.