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Neurocognitive Function After Proton Therapy in Children and Adolescents

ConditionPrimary Brain Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorTechnische Universität Dresden

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial population

30 patients with infra-tentorial or supra-tentorial tumors undergoing proton therapy, 30 patients undergoing surgical treatment and a control cohort of 30 adolescents. Therefore, a total of 90 persons will be evaluated.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Proton Therapy
Group B: No Radiotherapy - Surgical only group
Group C: Control Group

Trial outcomes

Primary outcomes

1

Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures)

Neurophysiological processes are examined while subjects perform the cognitive tests.

Time frame
2 years
2

Quality of Life Parameters (KINDL®)

QoL Parameters are measured and reported using KINDL® questionnaires for general quality of life and specific for oncologic diseases (also KINDL®). Scales for QoL items are 0-100 (with 100 being the Optimum, i.e. lower values indicating worse outcome). Evaluation is performed according to the standard published with the validated questionnaires (https://www.kindl.org/deutsch/fragebögen/)

Time frame
2 years

Secondary outcomes

1

dose-volume parameters to normal tissues, i.e. maximum irradiation doses, mean doses and doses to subvolumes

physical doses to substructures of the brain are collected and correlated with neurophysiological outcome measures

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

Gert und Susanna Mayer Stiftung

Collaborator

Source ClinicalTrials.gov
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