RecruitingOBSERVATIONAL

Neurocognitive Function After Proton Therapy in Children and Adolescents

This study aims to understand how proton therapy for brain tumours affects the thinking, learning, and memory skills of children and teenagers. Brain tumours are a common type of cancer in young people, and treatments can sometimes have side effects on the brain. Researchers will compare young people who received proton therapy with those who only had surgery for their brain tumour, and also with healthy children and teenagers. This helps them see if proton therapy leads to different short-term or medium-term changes in brain function, especially for tasks like planning and problem-solving. The goal is to find ways to improve care and reduce long-term effects for young patients.

At a glance

Status

Recruiting

Sponsor

Technische Universität Dresden

Enrolment target

Start

01 Sep 2019

Estimated completion

31 Dec 2027

Primary Brain Tumor

What is this study about?

Brain tumours are a serious illness that can affect children and teenagers. While treatments like surgery and radiotherapy are very effective at fighting the tumour, doctors also want to understand how these treatments might affect a young person's development, especially their thinking, learning, and memory (called 'neurocognitive function'). Proton therapy is a type of radiotherapy that is often considered to be more precise, meaning it aims to deliver radiation more directly to the tumour while sparing healthy tissue nearby.

This study focuses on children and teenagers who have been treated for a primary brain tumour. The main aim is to carefully examine how proton therapy might influence their 'executive functions' – these are the skills we use for planning, paying attention, solving problems, and managing our time. Researchers will use special tests and tools that can pick up even small changes in these brain activities. By doing this, they hope to get a clear picture of the short-term and medium-term effects of proton therapy.

To really understand the impact of proton therapy, the study will compare three groups of young people. One group will have received proton therapy, another group will have had only surgery for their brain tumour, and a third group will be made up of healthy children and teenagers who have not had a brain tumour. By comparing these groups, the researchers can see how different treatments affect brain function and help doctors make better decisions about care, ultimately aiming to improve the overall well-being and long-term outcomes for young patients with brain tumours.

Key takeaways

The study assesses how proton therapy impacts thinking, memory, and learning in young people with brain tumours.
It compares those with proton therapy to those with surgery only, and healthy young people.
Participants must be between 8 and 18 years old.
The study involves regular, hour-long tests of brain function.
Findings could help improve future treatments and care for children with brain tumours.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, young people need to be between 8 and 18 years old. They must have been diagnosed with a primary brain tumour, meaning the tumour started in the brain and hasn't spread from elsewhere. They also need to be well enough to take part in follow-up appointments and complete tests lasting about an hour each time. Importantly, they must not have had radiation treatment to their brain before.

For the group receiving proton therapy, they must be planned to have this treatment with specific radiation doses. The study also requires that their overall treatment is aiming to cure their tumour or provide them with a good quality of life for an extended period (at least three years). Both the young person and their parents or guardians will need to give their written permission to take part.

Young people cannot join the study if they are outside the 8-18 age range, if their brain tumour comes from cancer elsewhere in the body, or if they are having certain types of chemotherapy (intrathecal). Those who have chronic health problems that could affect the brain tests, or who cannot attend follow-up appointments, also wouldn't be able to participate. It's also important that they are not already part of another study that might clash with this one.

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.

Are you between 8 and 18 years old?
Have you been diagnosed with a primary brain tumour?
Have you NOT had radiation treatment to your brain before?
Are you able to attend follow-up appointments and complete hour-long brain tests?
Is your eyesight and hearing generally good (even with glasses/hearing aids)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have specific tests to check your thinking, learning, and memory skills. These tests typically take about one hour each time. These assessments will be done over a short and medium-term period after the treatment.

Depending on which group you are in, you will either continue with your planned proton therapy (if that is your treatment plan), or you will be in a group that only had surgery or a healthy group. The radiation therapy, if you are in that group, usually takes place five days a week for about 4-6 weeks, often as an outpatient. The study will track your progress through these neurocognitive tests for some time afterwards to see how you are doing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it might help doctors understand more about how treatments affect young people's brains, which could improve care for others in the future. For you, it might mean having your cognitive function monitored closely. Potential risks are generally low, mainly involving the time commitment for the assessments. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (3)

University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy
Verified postcode
Dresden, Germany· Recruiting
University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics
Verified postcode
Dresden, Germany· Recruiting
University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is proton therapy?

Proton therapy is a very precise type of radiation treatment that uses protons to target cancer cells, often reducing damage to healthy tissues around the tumour.

What does 'neurocognitive function' mean?

It means how well your brain works for things like thinking, learning, remembering, paying attention, and solving problems.

Will taking part change my treatment?

No, your treatment plan will be based on standard medical care or existing study protocols. This study observes and assesses the effects of that treatment.

How long will I need to be in the study?

The study looks at short-term and medium-term effects. This means you will have follow-up assessments over a period of time to track changes.

Who can see my personal information?

Your personal information will be kept confidential and used only for research purposes by the study team, following strict privacy rules.

How to find out more

Mechthild Krause, Prof. Dr.

mechthild.krause@uniklinikum-dresden.de +49 351 458 2238 Official trial record

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