Evaluating cognitive function after proton therapy in young patients with brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the short and medium-term effects of proton therapy on neurocognitive functions, particularly executive functions, in children and adolescents diagnosed with primary brain tumors. Participants will be compared to a control group of healthy individuals and another group who have undergone only surgical treatment. The study employs neurocognitive and neurophysiological research methods to detect subtle changes in cognitive performance. The goal is to evaluate the impact of different treatment modalities on the neuropsychological outcomes of pediatric brain tumor patients.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Mechthild Krause, Prof. Dr.
• Email: mechthild.krause@uniklinikum-dresden.de
• Phone: +49 351 458 2238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.