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Bright Light Therapy for Brain Cancer (SLEPBT Trial)

N/A
Recruiting
Led By Kimberly P Raghubar, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed and treated for a brain tumor at Texas Children's Hospital
Adequate vision for computerized tasks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once, at completion of intervention (week 6)
Awards & highlights

SLEPBT Trial Summary

This trial is looking at whether or not systematic bright light exposure can help improve symptoms of fatigue and cognitive efficiency in children who have previously been treated for a brain tumor.

Who is the study for?
This trial is for children and teens aged 10-18 who were treated for a brain tumor at Texas Children's Hospital, have mild to moderate fatigue, an IQ above 70, and are at least 3 years post-diagnosis. They must not have certain severe tumors or conditions like photophobia, seizures, migraines, or recent severe depression.Check my eligibility
What is being tested?
The study tests if bright light exposure can reduce fatigue and improve cognitive efficiency in pediatric brain tumor survivors. It's a pilot study to check how well participants stick with the treatment plan and see how effective it might be.See study design
What are the potential side effects?
Since this trial involves light exposure rather than medication, side effects may include discomfort from the brightness of the light but should generally be minimal compared to drug treatments.

SLEPBT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed and treated for a brain tumor at Texas Children's Hospital.
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I can see well enough to use a computer.
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I am between 10 and 18 years old.
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My cancer is not a high-grade glioma, brain stem glioma, or atypical teratoid rhabdoid tumor.
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I have been treated with surgery alone or surgery followed by proton beam radiation.

SLEPBT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once, prior to enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and once, prior to enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of approached participants who consent to study participation
Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
Percent of sessions completed during all 6 weeks of bright or dim light exposure
Secondary outcome measures
Change in fatigue outcome
Change in neurobehavioral outcome

SLEPBT Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Bright Light ExposureActive Control2 Interventions
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.
Group II: Dim Light ExposurePlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,372 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,521 Total Patients Enrolled
St. Jude Children's Research HospitalOTHER
429 Previous Clinical Trials
5,306,718 Total Patients Enrolled

Media Library

Bright Light Exposure Clinical Trial Eligibility Overview. Trial Name: NCT05340881 — N/A
Brain Tumor Research Study Groups: Dim Light Exposure, Bright Light Exposure
Brain Tumor Clinical Trial 2023: Bright Light Exposure Highlights & Side Effects. Trial Name: NCT05340881 — N/A
Bright Light Exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05340881 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of patient would you expect to see enroll in this type of medical study?

"This clinical trial is testing whether the study medication is effective for patients that have neoplasms, brain cancer, and are between the ages of 10-18. A total of 40 people will be enrolled in the trial."

Answered by AI

Would elderly individuals be able to participate in this research?

"Children aged 10 to 18 years old may participate in this trial, which is one of 80 such trials for minors. For elderly patients, this is one of 369 clinical trials."

Answered by AI
~12 spots leftby Feb 2025