Recruiting

Observational Study

Sponsor:

Baylor College of Medicine

Code:

NCT05340881

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Bright Light Exposure

Dim Light Exposure

Cognitive Assessment

Study Details

Brief summary:

Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action.

PRIMARY OBJECTIVE:

1. To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability.

SECONDARY OBJECTIVES:
2. To estimate the effect size of change in fatigue associated with bright light exposure.
3. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.

Conditions

Brain Tumor

Study ID

NCT05340881

Start date

Oct 14, 2022

Status verified date

Sep, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed and treated for a brain tumor at Texas Children's Hospital
  • Treated with either surgery only or surgery and proton beam radiation therapy
  • Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates
  • Currently or previously enrolled in longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-49380, H-26785, H-41705
  • Ages 10-18 years
  • At least 1 year post-diagnosis
  • Endorsed mild to moderate symptoms of fatigue on the PROMIS
  • Approval from Long-Term Survivorship provider
  • Adequate vision for computerized tasks
  • English-speaking
  • Intelligence Quotient (IQ) above 70

Exclusion Criteria:

  • Diagnosis and/or treatment for secondary malignancy in the past 12 months
  • Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention
  • Presence of photophobia or other eye diseases, seizures, and/or migraines
  • Use of photosensitizing medications
  • Current or previous use of light therapy

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Bright Light Exposure

Participants are exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work.

placebo comparator: Dim Light Exposure

Participants are exposed to exposed to dim light (equivalent intensity of <25 lux) using light glasses (Luminette) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work.

Interventions

Bright Light Exposure

Research coordinator will follow-up with participant on Days 2 \& 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued.

Dim Light Exposure

A placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses.

Cognitive Assessment

Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo).

Primary outcome measure

  • Percent of approached participants who consent to study participation [ Time Frame: Once, prior to enrollment ]
  • Percent of sessions completed during all 6 weeks of bright or dim light exposure [ Time Frame: At completion of bright or dim light exposure (Week 6) ]
  • Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors. [ Time Frame: Once, at completion of intervention (Week 6) ]

Central Contacts and Locations

Central contacts

Kimberly P Raghubar, PhD

832-822-3713kpraghub@texaschildrens.org

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Kimberly P Raghubar, PhD

(832)822-3713kpraghub@texaschildrens.org

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • Pediatric Oncology
  • Fatigue
  • Cognitive Late Effects
  • Light Exposure
  • Sleep
  • Mood
  • Brain Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-09-18.