Image

Neurocognitive Function After Proton Therapy in Children and Adolescents

Neurocognitive Function After Proton Therapy in Children and Adolescents

Recruiting
8-18 years
All
Phase N/A

Powered by AI

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.

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.

Eligibility

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

Study details
    Primary Brain Tumor

NCT04066465

Technische Universität Dresden

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.