Clinical trial · Observational
Neurocognitive Integrity After Proton Therapy for Brain Tumor
Prospective Evaluation of Neurocognitive Integrity After Proton Therapy for Brain Tumor
NCT07836478CI-TRIAL-00126566PROTON MINDnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumour | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The presence of cognitive impairment
- timeFrame
- From the end of Protontherapy through study completion, an average of 1 year.
- description
- The primary endpoint will be the presence of cognitive impairment during the first 5 years after enrollment, as measured by a comprehensive neuropsychological assessment.
Secondary outcomes (13)
- measure
- Perceived cognitive impairment
- timeFrame
- At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
- description
- For Functional Assessment of Cancer Therapy-cognition (FACT-cog) 37 items will be completed (score 1-4)
- measure
- Depressive symptoms
- timeFrame
- At baseline (pre - Protontherapy), 6 and 12 months post-treatment, and then annually for 5 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Radiological diagnosis, biopsy, or previous surgery * Concomitant medical therapy is allowed Exclusion Criteria: * Previous brain radiotherapy (any form) * High-grade gliomas * Patients with concomitant neurological or psychiatric disorders. * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.