What side effects are associated with this type of intervention?

Common treatments for brain tumors include surgery, radiation therapy, and chemotherapy. These treatments can lead to a range of side effects. Surgery may result in neurological deficits depending on the tumor's location. Radiation therapy can cause fatigue, cognitive decline, and endocrine dysfunction. Chemotherapy often leads to nausea, hair loss, and increased risk of infections. Systematic bright light exposure, a non-pharmacological intervention aimed at improving fatigue and cognitive symptoms, has shown promise in reducing fatigue and enhancing alertness with minimal side effects, making it a potentially valuable adjunctive treatment for brain tumor survivors.

What prior FDA approvals exist?

FDA-approved treatments for brain tumors include a variety of targeted therapies and immunotherapies. For instance, in non-small cell lung cancer (NSCLC) with brain metastases, gefitinib and erlotinib have shown central nervous system (CNS) activity. In melanoma, B-raf inhibitors like vemurafenib and dabrafenib, as well as the immunomodulator ipilimumab, have demonstrated efficacy in treating brain metastases. These treatments focus on targeting specific genetic mutations or enhancing the immune response to combat tumor cells. While systematic bright light exposure is a non-pharmacological approach aimed at improving fatigue and cognitive symptoms by regulating circadian rhythms, it is not directly comparable to these pharmacological treatments.

What other types of research exist?

Promising alternatives to systematic bright light exposure for brain tumor patients include melatonin supplementation, physical activity, and cognitive-behavioral strategies. These interventions have shown potential in regulating circadian rhythms and improving alertness.

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Bright Light Therapy for Brain Cancer (SLEPBT Trial)

N/A

Recruiting

Led By Heather M Conklin, 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

Must not have

Use of photosensitizing medications

Current or previous use of light therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once, at completion of intervention (week 6)

Summary

This trial tests if wearing special bright light glasses can help children and teens who had brain tumors feel less tired and think more clearly. The bright light might work by resetting their internal clocks, making them feel more awake.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication that increases my sensitivity to light.

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I have used light therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once, prior to enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in fatigue outcome

Change in neurobehavioral outcome

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include surgery, radiation therapy, and chemotherapy, each targeting tumor cells to reduce or eliminate the tumor. Systematic bright light exposure, a non-pharmacological intervention, works by regulating circadian rhythms and improving alertness, which can alleviate fatigue and cognitive symptoms often experienced by brain tumor patients. This matters because improved circadian regulation and alertness can enhance the quality of life and daily functioning for these patients, making it easier for them to carry out daily activities and potentially improving their overall prognosis.

Melatonin and its anti-glioma functions: a comprehensive review.Low-grade gliomas: clinical and pathobiological aspects.