Neurocognitive Function After Proton Therapy in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Brain Tumor. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurocognitive Function /executive Functions After Proton Therapy in Children and Adolescents.
Overview
Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. In a second step, these results are to be compared with 1. a group of children and adolescents who had only /exclusively had operative therapy and 2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive/neurophysiology brain research approaches are applied that may potentially visualize even small / subtle changes in mental activities/neurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.
Detailed description
Radio(chemo)therapy with protons is conducted according to current treatment standards or, for patients participating in a clinical intervention study, according to the study protocols of the GPOH. Only patients with prescribed radiation doses \> 40 Gy (RBE) will be included. Treatment planning, the target volume and radiotherapy will be performed according to the current treatment standards. For patients participating in a clinical intervention study, radiotherapy is corresponding to study protocol of the GPOH. Risk organs (e.g. brain stem, chiasma, optic nerves, gll. Lacrimals, lenses, inner ears and spine) are contoured and the radiation doses for these organs are limited according to institutional guidelines. Radiotherapy is performed according to guidelines, i.e. 5 days a week for 4-6 weeks, usually on an outpatient basis.
Primary outcome measures
- Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures) [Time frame: 2 years]
- Quality of Life Parameters (KINDL®) [Time frame: 2 years]
Secondary outcome measures (1)
- dose-volume parameters to normal tissues, i.e. maximum irradiation doses, mean doses and doses to subvolumes [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Germany · 3 centers
- University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychot — Dresden
- University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics — Dresden
- University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiati — Dresden
Identifiers
NCT: NCT04066465 · STR-ELBE-Pro-Kids-2019