Clinical trial · Observational
Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Neurobehavioral functions and quality of life (QoL) are the important outcome measurements after radiotherapy in patients with brain tumors and even head/neck cancers. However, few studies have focused on neurobehavioral functions and QoL after anti-cancer treatment particularly brain radiotherapy for pediatric/adolescent patients with brain tumors. This study thus aims to prospectively evaluate those functions in pediatric or adolescent patients with brain or head/neck tumors in order to provide useful information about their clinical outcomes. Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated using a neuropsychological battery, which includes general cognitive functions, intelligence, memory, executive functions, information processing and emotional/behavioral expressions. The QoL will be evaluated by the health-related QoL questionnaire. All participants will be examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment. Expected results: Patients'neurobehavioral functions and QoL will show significant improvement after treatment, and the improvement will not be diminished across each post-treatment phase.
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 |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard adjuvant local radiation therapy or cranial radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- pediatric/adolescent patients with brain tumors
- description
- A prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers
- interventionNames
- Radiation: standard adjuvant local radiation therapy or cranial radiation therapy
Primary outcomes (2)
- measure
- The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy
- timeFrame
- 1 week before the start of radiotherapy and 3 months after the start of radiotherapy
- description
- Intellectual functioning mainly includes subtests of Wechsler Intelligence scale for Children
- measure
- Neurobehavioral functions and psychosocial adjustments
- timeFrame
- 3 months after the start of radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients diagnosed with brain tumors or head/neck cancers who are no older than 18 years old * Patients should be considered indicated for receiving the subsequent course of local radiotherapy Exclusion Criteria: * Patients who received radiotherapy once before * Patients have visual and/or hearing impairments which obviously impede the administration of neurocognitive assessment * Patients cannot underwent brain MRI examination because of clinical contraindications, such as renal insufficiency (GFR \<30)
References
Publications (0)
Data not yet available