RecruitingInterventional

Looking for nerve problems caused by chemotherapy: determining the effectiveness of an early identification screening programme

This research is trying to find the best way to identify nerve problems, called chemotherapy-induced peripheral neuropathy (CIPN), in children who are having chemotherapy. These nerve problems can cause pain, weakness, or 'pins and needles' in the arms and legs, and can make walking difficult. Currently, there isn't a clear way to find these issues early, and we don't know if finding them sooner can help children recover better. This study will first run a small trial to check if a screening programme is practical and acceptable for children and their parents. It will compare the usual care children receive with a new screening method. The aim is to see if spotting these nerve issues early makes a difference to a child's health and well-being over time. Children aged 4 to 17 who are newly diagnosed and at high risk of CIPN can take part. The study is run from Alder Hey Children's NHS Foundation Trust in the UK.

At a glance

Status

Recruiting

Sponsor

Alder Hey Children's NHS Foundation Trust

Enrolment target

Start

03 Aug 2023

Estimated completion

31 Dec 2026

Chemotherapy induced peripheral neuropathy

What is this study about?

When children receive chemotherapy to treat their cancer, it can sometimes affect their nerves. This is known as chemotherapy-induced peripheral neuropathy (CIPN). These nerves are outside of the brain and spine, mainly in the arms and legs. When these nerves are damaged, it can cause problems like pain, muscle weakness, odd sensations such as 'pins and needles', or even issues like constipation. If these problems become severe, they can make walking and keeping balance difficult.

Right now, healthcare professionals don't have a standard or proven way to reliably identify CIPN early on. Also, we don't know if finding these nerve problems sooner means that children will have better long-term health outcomes. This study has been designed to explore these important questions.

Before launching a large, full-scale study, the researchers want to carry out a smaller, 'pilot' study. This is to make sure that the way they plan to identify these nerve problems is practical and works well for both children and their families. They will compare a new screening approach designed to spot nerve issues earlier with the standard care that children usually receive. By doing this, they hope to learn the best way to help children facing these potential side effects.

Key takeaways

This study is testing a new way to spot nerve problems early in children on chemotherapy.
Early detection of 'chemotherapy-induced peripheral neuropathy' (CIPN) might lead to better health outcomes.
It's a 'pilot' study first, to make sure the screening program is practical and acceptable.
Children aged 4-17 at high risk of CIPN can take part.
The study compares a new screening method with usual care.
It runs until June 2026 and is based at Alder Hey Children's NHS Foundation Trust.

Who may be eligible?

This study is looking for children aged between 4 and 17 years old who have recently been diagnosed with certain types of cancer and are starting chemotherapy. These particular cancers and treatments are known to carry a higher risk of causing nerve problems.

Children are considered at high risk if their treatment includes a specific drug called vincristine, which is often used for conditions like Acute Lymphoblastic Leukaemia (ALL), Wilms Tumour, Rhabdomyosarcoma, or some low-grade brain tumours. Studies have shown these groups of children often experience this type of nerve issue.

Children cannot take part if they are very unwell, have other health conditions that might make the tests unsafe, or if their cancer has returned. Also, children under 4 years old cannot join because the assessments used in the study are not suitable for very young children.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child newly diagnosed with cancer?
Is your child aged between 4 and 17 years old?
Is your child's chemotherapy treatment known to put them at higher risk of nerve problems (e.g., involves vincristine)?
Is your child generally stable and well enough to take part in assessments?
Has your child's cancer not returned after previous treatment?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will first give their permission (known as informed consent). After an initial check-up, children will be randomly assigned to one of two groups. One group will receive the usual care, while the other group will be part of a new screening programme designed to find nerve problems early. The study doesn't specify if this involves extra doctor visits, tests, or medication beyond the standard treatment. The main aim is to see how acceptable and practical the screening programme is rather than focusing on specific treatment changes. The study is expected to run from August 2023 to June 2026.

Potential risks and benefits

The study information available does not detail specific benefits or risks for children taking part. However, participating in research like this helps medical teams understand more about conditions and improve care for other children in the future. Any research involvement comes with the right to withdraw at any time without affecting your child's medical care. Researchers always aim to prioritise the safety and well-being of participants.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alder Hey Children's NHS Foundation Trust
Unverified
Liverpool, England

Common questions

What is chemotherapy-induced peripheral neuropathy (CIPN)?

It's a type of nerve damage that can happen in some children because of their chemotherapy. It mainly affects nerves in the arms and legs and can cause pain, weakness, or strange feelings like 'pins and needles'.

Why is this study important?

Currently, there's no clear way to find these nerve problems early, and we don't know if finding them sooner helps children get better. This study aims to find the best way to help identify these issues.

Who is funding this research?

The study is funded by charitable organisations at Alder Hey Children's NHS Foundation Trust and the Isle of Man Anti-Cancer Association.

How long will the study last?

The study began in August 2023 and is expected to finish in June 2026.

Who can I contact for more information?

You can contact Dr. Helen Hartley at helen.hartley@alderhey.nhs.uk for more details.

How to find out more

Helen Hartley

helen.hartley@alderhey.nhs.uk +44 151 228 4811 x2935 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.