Neurocognitive Function After Proton Therapy in Children and Adolescents

NCT04066465 | Recruiting

• 1 other identifier: STR-ELBE-Pro-Kids-2019
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.a group of children and adolescents who had only /exclusively had operative therapy and
2. 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.

Conditions

Primary Brain Tumor

Keywords

Brain Tumor; children and adolescents; neurocognitive function; neurocognitive or neuropsychological outcome; quality of life, LOQ; EEG; Neuropsychological Tests; Proton Therapy; Neurosurgical Treatment

Outcome Measures

Primary Outcomes (2)

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

  Neurophysiological processes are examined while subjects perform the cognitive tests.

  2 years

• 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/)

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (3)

Proton Therapy

Patients receive proton Radio(chemo)therapy according to clinical standard. Proton Treatment is indicated BEFORE inclusion into the trial ans is not part of the trial. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases. In addition to the treatment parameters of the radio(chemo)therapy protocol, further radiation doses to brain substructures and organs at risk are documented.

No Radiotherapy - Surgical only group

Patients are included AFTER surgery of their brain tumour and receive no radiotherapy due to their disease (i.e. according to clinical standard). This Treatment is not part of the trial, but stratifies the Patient in this second Group. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.

Control Group

Healthy kids are recruited as Standard Group. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Gert und Susanna Mayer Stiftung: collaborator

Study Sites (3)

University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy

Dresden, Saxony, 01307, Germany

RECRUITING

University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics

Dresden, Saxony, 01307, Germany

RECRUITING

University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mechthild Krause, Prof. Dr.

  University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

  STUDY CHAIR

Central Study Contacts

Mechthild Krause, Prof. Dr.

CONTACT

+49 351 458 2238; mechthild.krause@uniklinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: August 26, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)