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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Bright Light Therapy for Brain Cancer is an effective treatment?

The available research shows that Photodynamic Therapy (PDT), a similar light-based treatment, has been used for brain cancer and has shown promising results. For example, one study found that patients with a type of brain cancer called glioblastoma multiforme lived longer after receiving PDT compared to those who received standard treatments. Specifically, the median survival time was 22 months for new cases and 9 months for recurring cases with PDT, compared to 15 and 3 months, respectively, with standard treatments. This suggests that light-based therapies can be effective in treating brain cancer. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Bright Light Therapy for brain cancer?

Photodynamic therapy (PDT), which involves light exposure, has shown promise in treating brain tumors by increasing survival rates compared to standard treatments. Clinical studies indicate that PDT can prolong median survival for patients with glioblastoma multiforme, a type of brain cancer, suggesting that light-based therapies may be effective. ^{1 2 3 4 5}

What safety data exists for bright light therapy in treating brain cancer?

The safety data for bright light therapy (BLT) shows that it is generally well-tolerated with few side effects. Studies have reported minor side effects such as headache, eye strain, irritability, and nausea, primarily in psychiatric populations. In healthy individuals, side effects like blurring were observed but were minimal. In cancer survivors, personalized trials showed mixed results, with some experiencing benefits and others reporting no change or increased depressive symptoms. Overall, BLT is considered safe, but individual responses can vary. ^{6 7 8 9 10}

Is bright light therapy safe for humans?

Bright light therapy is generally considered safe, with some studies reporting minor side effects like eye strain, irritability, and nausea. In healthy individuals, side effects such as headaches were not reported, although some experienced blurring. Overall, it is well-tolerated, especially when using newer light setups. ^{6 7 8 9 10}

Is Bright Light Exposure a promising treatment for brain cancer?

The information provided does not mention Bright Light Exposure as a treatment for brain cancer. Instead, it discusses Photodynamic Therapy (PDT), which is a different treatment that shows promise in selectively destroying tumor cells and potentially improving survival rates when used alongside other treatments. ^{1 2 3 11 12}

How does Bright Light Therapy differ from other treatments for brain cancer?

Bright Light Therapy is unique because it involves exposure to bright light, which is different from traditional treatments like surgery, chemotherapy, or radiation. While other treatments focus on physically removing or destroying cancer cells, Bright Light Therapy may work by influencing biological processes in the brain, potentially offering a non-invasive option. ^{1 2 3 11 12}

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

Eligibility Criteria

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.

Approval from Long-Term Survivorship provider

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of cerebral glioma--a review Part I--a biological basis. [2006]

2. Scotland pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of cerebral glioma - a review. Part II - clinical studies. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Photodynamic diagnosis and therapy and the brain. [2015]

4. Ukraine pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in the treatment of glioma. [2016]

5. Singapore pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumours. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

7. Switzerland 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The acute side effects of bright light therapy: a placebo-controlled investigation. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of bright light therapy in bipolar depression. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. [2004]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Photoradiation therapy of brain tumours. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of brain tumors. [2019]