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Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02608762
Enrollment
72
Registered
2015-11-20
Start date
2013-09-01
Completion date
2023-12-31
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Keywords

Pediatric brain tumors, Radiation therapy, Neurobehavioral functions, Proton radiotherapy

Brief summary

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.

Interventions

RADIATIONstandard adjuvant local radiation therapy or cranial radiation therapy

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy1 week before the start of radiotherapy and 3 months after the start of radiotherapyIntellectual functioning mainly includes subtests of Wechsler Intelligence scale for Children
Neurobehavioral functions and psychosocial adjustments3 months after the start of radiotherapyIn this study, evaluations of neurocognitive functions include memory scores of verbal memory (NEPSY-II),memory scores of non-verbal memory (NEPSY-II) raw scores of executive functions (NEPSY-II), raw scores of processing speed (NEPSY-II), raw scores of attention (Continuous Performance Test, CPT). Evaluations of psychosocial adjustments mainly include severity scores of behavioral problems (Achenbach System of Empirically Based Assessment),scores of behavioral problems(Vineland Adaptive Behavior Scale), scores of parental stress (Parenting Stress Index, PSI) and scores on the scale for quality of life (Child Health Questionnaire, CHQ).

Countries

Taiwan

Contacts

Primary ContactChi-Cheng Yang, Ph.D.
ccyang@mail.cgu.edu.tw886-988378478
Backup ContactShinn-Yn Lin, M.D.
rt3126@gmail.com+886-33281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026