Clinical trial NCT02608762: Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Keywords: Pediatric brain tumors
Radiation therapy
Neurobehavioral functions
Proton radiotherapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited.

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.


Eligibility criteria: 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)

Primary outcomes:
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
measure: Neurobehavioral functions and psychosocial adjustments
timeFrame: 3 months after the start of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: