Bright Light Therapy for Brain Cancer

(SLEPBT Trial)

Overseen By Kimberly P Raghubar, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Photosensitizing medications

Disqualifiers: Secondary malignancy, Suicidal ideation, Photophobia, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light exposure can reduce fatigue and improve cognitive skills in young people treated for a brain tumor. Participants will wear special light glasses each morning for 30 minutes over a 6-week period to determine if bright light differs from dim light in its effects. Children and teens who have been treated for a brain tumor, experience mild to moderate fatigue, and can engage in computerized tasks might be suitable candidates. The findings could inform the design of a larger study to better understand this treatment's effectiveness. As an unphased trial, this study offers a unique opportunity to contribute to early research that could lead to new treatments for fatigue in young brain tumor survivors.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using photosensitizing medications, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using photosensitizing medications (medications that make your skin sensitive to light).

What prior data suggests that bright light therapy is safe for children treated for a brain tumor?

Research has shown that bright light therapy is generally safe and easy to manage. Studies have found it can reduce tiredness and improve sleep. For cancer survivors, morning bright light therapy has reduced fatigue and improved sleep quality. This suggests it might also help children and teens who have had brain tumors feel more awake and less fatigued.

The therapy involves using light glasses to expose participants to bright light for a short time each day. This method is simple and carries low risks. Overall, bright light therapy is considered safe and can be a helpful part of daily routines for those seeking to reduce fatigue and enhance mental sharpness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which typically involve surgery, chemotherapy, and radiation, bright light therapy offers a completely different approach. This method uses bright light exposure (1,000 lux) delivered through special light glasses, which is a novel, non-invasive delivery method that stands out from traditional cancer treatments. Researchers are excited about this therapy because it might improve cognitive function and mood with minimal side effects, potentially enhancing quality of life for patients during treatment.

What evidence suggests that bright light exposure might be an effective treatment for fatigue and cognitive symptoms in pediatric brain tumor survivors?

Research has shown that bright light therapy (BLT), which participants in this trial may receive, can alleviate tiredness and issues like slow thinking and trouble focusing. Studies have found that BLT may improve sleep problems in cancer patients by influencing the body's internal clock and certain brain areas. It is safe, easy to use, and affordable. BLT has demonstrated positive effects on sleep and may also aid mental health. For children and teens who have had brain tumors, this therapy might reduce tiredness and enhance brain function. Meanwhile, another group in this trial will receive dim light exposure as a comparator. ^{1 2 5 6 7}

Who Is on the Research Team?

Kimberly P Raghubar, PhD

Principal Investigator

Baylor College of Medicine - Texas Children's Hospital

Heather M Conklin, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed and treated for a brain tumor at Texas Children's Hospital.

Your IQ is higher than 70.

I experience mild to moderate fatigue.

Exclusion Criteria

I am taking medication that increases my sensitivity to light.

I have had thoughts of suicide or severe depression in the last year.

I have used light therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including psychological testing and saliva collection

1 week

1 visit (in-person)

Treatment

Participants are exposed to either bright or dim light for 30 minutes each day, Monday to Friday, for 6 weeks

6 weeks

Weekly remote check-ins

End of Treatment Assessment

Participants complete end of treatment assessments including psychological testing and saliva collection

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bright Light Exposure
• Dim Light Exposure

Trial Overview 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.

How Is the Trial Designed?

Group I: Bright Light Exposure Active Control 2 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 Exposure Placebo Group 2 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.

Bright Light Exposure is already approved in United States, European Union for the following indications:

Approved in United States as Bright Light Therapy for:

• Fatigue
• Circadian rhythm disorders
• Sleep problems

Approved in European Union as Bright Light Therapy for:

• Fatigue
• Seasonal affective disorder
• Circadian rhythm disorders

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

Photodynamic therapy (PDT) has been effectively used for 25 years to treat malignant brain tumors by using a photosensitizer that selectively targets tumor cells, followed by light activation to destroy the tumor.

PDT is considered a valuable addition to surgical and conventional therapies, supported by extensive laboratory studies and clinical trials focusing on its application in brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of cerebral glioma - a review. Part II - clinical studies. Stylli, SS., Kaye, AH.[2007]

Photodynamic therapy (PDT) shows promise in extending median survival for patients with malignant brain tumors, with 22 months for primary glioblastoma multiforme compared to 15 months with standard treatment.

PDT is generally well tolerated, though some patients may experience increased intracranial pressure and prolonged skin sensitivity to sunlight, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic diagnosis and therapy and the brain. Kostron, H.[2015]

In a study involving 42 patients with major depressive disorder, both bright white-light therapy (2,500 lux) and dim red-light therapy (50 lux) were administered daily for seven days without any significant differences in side effects between the two treatments.

This suggests that light therapy, regardless of intensity, may be a safe option for treating depression without increasing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. Volz, HP., Mackert, A., Stieglitz, RD.[2004]

Photodynamic therapy (PDT) effectively targets tumors by using a photosensitizer, like haematoporphyrin derivative (HpD), which selectively accumulates in various grades of gliomas, with the highest uptake in glioblastoma multiforme.

Clinical trials indicate that PDT is primarily used as an adjuvant therapy after tumor resection, showing promise in enhancing treatment outcomes for cerebral tumors, particularly when combined with stereotactic techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumours. Kaye, AH., Hill, JS.[2020]

In a study involving nine cancer survivors, bright white light therapy (BWL) showed mixed results for reducing depressive symptoms, with two participants experiencing significant improvement, while others reported no change or even increased symptoms.

Despite the varied responses, eight out of nine participants recommended personalized trials of BWL, suggesting that individual assessments may help determine its effectiveness for managing depression in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Usefulness of Bright White Light Therapy for Depressive Symptoms in Cancer Survivors: Results from a Series of Personalized (N-of-1) Trials. Kronish, IM., Cheung, YK., Julian, J., et al.[2020]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

Photodynamic therapy (PDT) has been established as an effective adjuvant treatment for various cancers, including cerebral glioma, by selectively destroying tumor cells through photochemical and photobiological processes.

Extensive laboratory studies and clinical trials have been conducted using different photosensitizers, highlighting the importance of environmental and genetic factors in determining the effectiveness of PDT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of cerebral glioma--a review Part I--a biological basis. Stylli, SS., Kaye, AH.[2006]

Photodynamic therapy (PDT) is a promising treatment for brain tumors, particularly gliomas, as it selectively targets and destroys tumor cells while sparing healthy tissue.

While PDT has been shown to be clinically safe, further clinical trials are needed to establish its efficacy and optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumors. Popovic, EA., Kaye, AH., Hill, JS.[2019]

A study involving healthy young adults found that a single 30-minute session of bright light therapy (10,000 lux) did not lead to significantly more side effects compared to dim red light exposure, suggesting it is safe for short-term use in this population.

While both groups reported slight increases in eye strain and blurred vision, these effects were not significantly higher in the bright light therapy group, indicating that adverse effects may be less common in non-clinical populations than previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute side effects of bright light therapy: a placebo-controlled investigation. Botanov, Y., Ilardi, SS.[2023]

In a study of 32 outpatients with bipolar depression, bright light therapy (BLT) significantly improved depression scores compared to dim light, with response rates of 81% for BLT versus 19% for dim light.

BLT was found to be a safe add-on treatment, with similar side effects to dim light exposure, indicating its potential as an effective therapy for bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bright light therapy in bipolar depression. Yorguner Kupeli, N., Bulut, NS., Carkaxhiu Bulut, G., et al.[2018]

Photodynamic therapy (PDT) shows promising results in treating malignant brain tumors, with improved one and two-year survival rates compared to standard treatments.

Patients receiving PDT experienced an increase in overall median survival, suggesting that this therapy could be a beneficial option in neurooncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in the treatment of glioma. Zavadskaya, ТS.[2016]

Photoradiation therapy has shown promise in selectively destroying cerebral gliomas, effectively reaching depths of up to 1 cm in tumor tissue, indicating its potential for localized treatment.

Clinical studies using haematoporphyrin derivative and red laser light have demonstrated that this therapy is well tolerated by patients and may serve as a valuable adjuvant treatment for cerebral tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoradiation therapy of brain tumours. Kaye, AH.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9645769/

Examining the Efficacy of Bright Light Therapy on Cognitive ... Several studies have shown that bright light therapy may improve cognition, potentially due to its effects on the circadian system via brain regions that ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425005901

Effectiveness and Safety of Bright Light Therapy in ... BLT is well-tolerated, easy to administer and has relatively low costs. BLT appears to be effective for sleep disturbances in oncological patients.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40185343/

Effectiveness and Safety of Bright Light Therapy in ... Light therapy has showed promising results, providing a safe and potentially effective treatment for a variety of psychological symptoms.

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6874

The Effect of Systematic Light Exposure on Sleep in a Mixed ... The results suggest that systematic bright light exposure in the morning may have beneficial effects on sleep in fatigued cancer survivors.

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.815872/full

Preventing Sleep Disruption With Bright Light Therapy ... In the current study, women exposed to dim red light had decreased wake-time activity during chemotherapy treatment weeks of cycle 1 and cycle 4 ...

6. mountsinai.org mountsinai.org/about/newsroom/2018/bright-white-light-therapy-reduces-fatigue-among-cancer-survivors

"Bright White Light Therapy Reduces Fatigue Among ... Cancer survivors who used systematic bright white light therapy in the mornings experienced beneficial effects with sleep and also felt less fatigued.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-07130

Systematic Bright Light Exposure for Improving Fatigue and ... This clinical trial evaluates systematic bright light exposure for improving fatigue and thinking efficiency among pediatric brain tumor survivors.