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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Brain Tumor

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

Study type: Observational

Funder types: Other

Identifiers

NCT02608762

102-5729A3

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

72 participants in 1 patient group

pediatric/adolescent patients with brain tumors

Description:

A prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers

Treatment:

Radiation: standard adjuvant local radiation therapy or cranial radiation therapy