Neurocognitive Function After Proton Therapy in Children and Adolescents

Launched by TECHNISCHE UNIVERSITÄT DRESDEN · Aug 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how proton therapy, a type of radiation treatment, affects the thinking and memory skills of children and teenagers with primary brain tumors. Researchers want to find out if proton therapy has different effects on cognitive abilities compared to those who only had surgery and a group of healthy children. By using advanced brain research techniques, the study aims to identify even small changes in mental functions after treatment, which could help improve care for young patients.

To be eligible for this trial, participants need to be between 8 and 18 years old, have a primary brain tumor, and must not have had any previous radiation therapy. They should be able to take part in tests that measure their cognitive skills, have good vision and hearing, and be willing to attend follow-up appointments. If a child joins the study, they can expect to undergo several neuropsychological tests, which will help researchers track any changes in their thinking abilities over time. This trial is currently recruiting participants, and it aims to better understand how different treatments impact the cognitive health of young patients battling brain tumors.

Gender

ALL

Eligibility criteria

• • Indication: Patients with primary brain tumor
• Inclusion Criteria:
• • all groups: Patients in childhood and adolescence between 8-18 years of age
• • all groups: no prior radiotherapy of the brain,
• • all groups: The patient is able to perform repeated neuropsychological tests (approx. 1 hour per examination),
• • all groups: corrected visual acuity not impaired below 80% or no subjective indication of visual acuity impairment,
• • all groups: corrected hearing not impaired or no subjective evidence of hearing impairment,
• • all groups: Patient is able to perform follow-up examinations,
• • all groups: written consent of the patient/parent or guardian.
• • Brain tumour groups with/without irradiation: Primary brain tumour
• • brain tumor groups with/without radiation: curative or long-term palliative intention of therapy
• • brain tumor groups with/without irradiation: life expectancy \> 3 years
• • Irradiation group only: planned proton therapy with a local radiation dose of at least 40 Gy(RBE)
• Exclusion Criteria:
• • Patients under 8 or over 18 years of age (We limit the study to children over 8 years of age due to the fact that executive functions mature very late.)
• • Brain metastases from extracerebral tumors
• • Patient receives intrathecal chemotherapy
• • pure palliative treatment concept
• • The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination).
• • Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations.
• • The patient is not in a position to perform follow-up examinations
• • no written consent of the patient / parent or legal guardian
• • Participation in an intervention study whose procedures contradict those of the present study