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

Brain Tumor Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02608762
• Other study ID #: 102-5729A3
• Status: Recruiting
• Start date: September 1, 2013
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chi-Cheng Yang, Ph.D.
• Phone: 886-988378478
• Email: ccyang[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Radiation:
• standard adjuvant local radiation therapy or cranial radiation therapy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy	Intellectual functioning mainly includes subtests of Wechsler Intelligence scale for Children	1 week before the start of radiotherapy and 3 months after the start of radiotherapy
Primary	Neurobehavioral functions and psychosocial adjustments	In 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).	3 months after the start of radiotherapy