Evaluating cognitive function after proton therapy in young patients with brain tumors
Neurocognitive Function /executive Functions After Proton Therapy in Children and Adolescents.
This study is trying to see how proton therapy affects thinking skills in children and teens with brain tumors compared to those who had surgery or are healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Dresden, Saxony and 2 other locations) |
| Trial ID | NCT04066465 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 8-18 years with a primary brain tumor who have not previously received brain radiation.
Not a fit: Patients with prior brain radiotherapy or those unable to complete neuropsychological tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how proton therapy affects cognitive development in children, potentially leading to improved treatment protocols.
How similar studies have performed: Other studies have shown promising results in evaluating cognitive outcomes in pediatric patients with brain tumors, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden, Saxony and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.