Neurocognitive Integrity After Proton Therapy for Brain Tumor
ConditionCentral Nervous System Tumour
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
Radiation therapy remains a cornerstone in the management of both benign and malignant intracranial tumors, either as monotherapy or combined with surgery and/or chemotherapy. Despite its therapeutic benefits, it is frequently associated with potential long-term adverse effects, with neurotoxicity posing a major challenge, especially in young patients affected by benign primary tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary tumors of Brain Tumor (CNS), benign and malignant
Age ≥ 18 years
Patients able to speak and read the local language(s) fluently
Acceptance and signature of informed consent
Disqualifiers
Previous brain radiotherapy (any form)
High-grade gliomas
Patients with concomitant neurological or psychiatric disorders.
Pregnancy
Trial population
Patients affected by primary central nervous system tumors and eligible for protontherapy as adjuvant or radical treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The presence of cognitive impairment
The primary endpoint will be the presence of cognitive impairment during the first 5 years after enrollment, as measured by a comprehensive neuropsychological assessment.
Time frame
From the end of Protontherapy through study completion, an average of 1 year.Secondary outcomes
1
Perceived cognitive impairment
For Functional Assessment of Cancer Therapy-cognition (FACT-cog) 37 items will be completed (score 1-4)
Time frame
At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.2
Depressive symptoms
At Beck Depression Inventory-II (BDI-II) 21 items will be completed (score 0-3)
Time frame
At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.3
Anxiety
For State-Trait Anxiety Inventory (STAI) 40 items will be completed (score 1-4)
Time frame
At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.4
Quality of Life data (QoL) - EORTC QLQ C30 questionnaires.
For EORTC QLQ C30, 30 items will be completed (score 1-4).
Time frame
At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: