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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ once, prior to enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once, prior to enrollment
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed and treated for a brain tumor at Texas Children's Hospital.I am taking medication that increases my sensitivity to light.Your IQ is higher than 70.I have had thoughts of suicide or severe depression in the last year.I experience mild to moderate fatigue.I can see well enough to use a computer.I am between 10 and 18 years old.My cancer is not a high-grade glioma, brain stem glioma, or atypical teratoid rhabdoid tumor.I have used light therapy before.You were diagnosed with the condition at least 3 years ago.I have been treated with surgery alone or surgery followed by proton beam radiation.I experience sensitivity to light, have eye diseases, seizures, or migraines.I have not been diagnosed or treated for another cancer in the last year.You are already taking part in other studies about how the brain works after having a tumor as a child.
Research Study Groups:
This trial has the following groups:- Group 1: Dim Light Exposure
- Group 2: Bright Light Exposure
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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