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

NCT ID: NCT02608762

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pediatric/adolescent patients with brain tumors

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

standard adjuvant local radiation therapy or cranial radiation therapy

Intervention Type RADIATION

Interventions

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standard adjuvant local radiation therapy or cranial radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chi-Cheng Yang, Ph.D.

Role: CONTACT

886-988378478

Shinn-Yn Lin, M.D.

Role: CONTACT

+886-33281200 ext. 7172

Facility Contacts

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Shinn-Yn Lin, M.D.

Role: primary

+886-33281200 ext. 7172

Other Identifiers

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102-5729A3

Identifier Type: -

Identifier Source: org_study_id

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