Systematic Light Exposure in Pediatric Brain Tumor Survivors

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05340881
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Bright Light Exposure — BEHAVIORAL
    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 — BEHAVIORAL
    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 — OTHER
    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).

Study Details

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.

Key Dates

Start date
Oct 14, 2022
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Percent of approached participants who consent to study participation [ Time Frame: Once, prior to enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030
Kimberly P Raghubar, PhD
[email protected]
(832)822-3713

Find similar trials in Houston, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Texas Children's Hospital· Houston, TX

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