Photobiomodulation for Cancer-Related Cognitive Impairment

Overseen By Cancer Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arash Asher, MD

Disqualifiers: Pregnancy, Brain tumor, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special light therapy helmet (THOR LED Photobiomodulation Helmet - Therapeutic) can improve thinking and memory problems in cancer survivors. Researchers will divide participants into two groups: one using a real helmet and the other using a fake one that doesn’t emit light. The study targets individuals who have survived cancer, completed treatment more than six months ago, and are experiencing memory or thinking issues. Participants will use the helmet three times a week for six weeks and will complete surveys about their cognitive abilities and quality of life. As an unphased trial, this study provides a unique opportunity to explore innovative therapy for cognitive improvement.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, some ongoing treatments like endocrine therapy or stable maintenance therapies are allowed.

What prior data suggests that the THOR LED Photobiomodulation helmet is safe for cancer survivors with cognitive impairment?

Research has shown that photobiomodulation (PBM) therapy, which uses red to near-infrared light, is generally safe for humans. Studies have found that the THOR LED Photobiomodulation Helmet, similar to the one used in this trial, has been used without major safety issues.

For example, research suggests that this type of light treatment can be safely applied to the scalp to help improve brain function. One study found that using near-infrared light treatment was safe and even beneficial for people with Alzheimer's, enhancing their thinking and daily activities.

No significant negative side effects have been reported, indicating that the treatment is likely well-tolerated by most people. However, since this is a new area of research, participants should report any unusual symptoms to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the THOR LED Photobiomodulation Helmet for cancer-related cognitive impairment because it offers a non-invasive approach, using light therapy to potentially improve brain function. Unlike typical medications for cognitive impairment, which often rely on pharmaceuticals, this helmet uses specific wavelengths of light to stimulate brain activity. This innovative method could offer an alternative for those who can't tolerate standard medications, and it might reduce cognitive symptoms without the side effects associated with drugs.

What evidence suggests that this trial's treatments could be effective for cancer-related cognitive impairment?

Research shows that photobiomodulation, which uses red or near-infrared light, can enhance brain function by increasing blood flow and boosting energy production in cells. Studies have found that this treatment helps with memory and thinking problems in aging mice. It has also shown promise in improving brain function in people with long-COVID. In this trial, participants will join either the Intervention Arm, using the THOR LED Photobiomodulation Helmet in a therapeutic setting, or the Control Arm, using the helmet in a non-therapeutic setting. These findings suggest that the THOR LED Photobiomodulation Helmet might help cancer survivors with memory and thinking issues, though more research is needed to confirm its effectiveness for this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Arash Asher, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who've finished treatment between 6 months and 5 years ago, are experiencing cognitive issues, and can read English or Spanish. It's not for those pregnant, nursing, with certain neurological conditions, previous brain tumors/CNS metastasis, or past use of specific advanced cancer treatments.

Inclusion Criteria

I was previously diagnosed with a stage I-III non-brain solid tumor or lymphoma.

Self-reported cognitive complaints (score ≤ 54 on the Functional Assessment of Cancer Therapy-Cognition, Version 3, Perceived Cognitive Impairment subscale)

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria

Current pregnancy or nursing status

I have never had a brain tumor or cancer spread to my brain.

I have had treatments like spinal chemotherapy, CAR-T therapy, or a bone marrow transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the THOR LED Photobiomodulation helmet 3 times per week for 6 weeks. The intervention group uses the helmet in a therapeutic setting, while the control group uses it in a placebo setting.

6 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of cognitive symptoms, cognitive abilities, quality of life, depression, and anxiety.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• THOR LED Photobiomodulation Helmet - Control
• THOR LED Photobiomodulation Helmet - Therapeutic

Trial Overview The study tests if a THOR LED Photobiomodulation helmet improves cognition in cancer survivors when used thrice weekly for six weeks. Participants are randomly assigned to either the therapeutic setting (active) group or placebo setting (inactive) group.

How Is the Trial Designed?

Group I: Intervention Arm - Therapeutic Setting Experimental Treatment 1 Intervention

Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks

Group II: Control Arm - Non-Therapeutic Setting Placebo Group 1 Intervention

Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks

Who Is Running the Clinical Trial?

Arash Asher, MD

Lead Sponsor

Trials

6

Recruited

220+

Thor Photomedicine

Collaborator

Trials

1

Recruited

30+

Thor

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The RGn500 device, which combines photonic and magnetic emissions, showed a neuroprotective effect in a mouse model of Alzheimer's disease when applied daily for 10 minutes, leading to memory restoration and normalization of key Alzheimer's markers.

This treatment demonstrated similar therapeutic efficacy to traditional pharmacological approaches, suggesting it could be a promising alternative for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of a new photobiomodulation technique against Aβ25-35 peptide-induced toxicity in mice: Novel hypothesis for therapeutic approach of Alzheimer's disease suggested. Blivet, G., Meunier, J., Roman, FJ., et al.[2022]

In a pilot study involving healthy individuals over 45 years old, near-infrared transcranial photobiomodulation therapy (PBM-T) significantly improved motor function, memory performance, and processing speed compared to a placebo group.

The therapy was administered safely at home using a specialized helmet device, with no reported adverse effects, suggesting that PBM-T could be a promising method for enhancing cognitive abilities in middle-aged individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Near-Infrared Light 1068 nm Upon Memory Performance in Aging Healthy Individuals: A Pilot Study. Dougal, G., Ennaceur, A., Chazot, PL.[2021]

Photobiomodulation (PBM) uses red or near-infrared light to potentially heal and protect brain tissue affected by various disorders, including traumatic injuries, degenerative diseases, and psychiatric conditions.

Recent advancements, such as affordable LED light-emitting helmets, have made it easier to apply PBM to the brain, showing promise for cognitive enhancement and treatment of brain disorders based on pre-clinical and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shining light on the head: Photobiomodulation for brain disorders. Hamblin, MR.[2020]

In a study involving 5 patients with mild to moderately severe dementia, treatment with near-infrared photobiomodulation (PBM) therapy for 12 weeks led to significant cognitive improvements, as measured by the Mini-Mental State Exam (MMSE) and Alzheimer's Disease Assessment Scale (ADAS-cog).

The therapy was associated with positive changes in daily functioning, sleep quality, and reduced anxiety, with no reported negative side effects, highlighting PBM's potential as a safe and effective home treatment option for dementia and Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report. Saltmarche, AE., Naeser, MA., Ho, KF., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05855694

Photobiomodulation for Cancer-Related Cognitive ... This is a single site, pilot randomized, double blinded control trial designed to assess changes in cognitive symptoms in cancer survivors with cancer-related ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6041198/

Brain Photobiomodulation Therapy: A Narrative Review - PMC Transcranial low-level laser therapy improves brain mitochondrial function and cognitive impairment in D-galactose–induced aging mice. Neurobiol Aging. 2017 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671386/

Photobiomodulation: shining a light on depression - PMC Photobiomodulation (PBM), which involves the application of red or near-infrared light, modulates physiological processes by enhancing cerebral blood flow.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jbio.202200391

Use of either transcranial or whole‐body ... Photobiomodulation (PBM) treatments with a helmet (transcranial) or bed (whole-body) demonstrated improved cognitive functions in long-COVID ...

5. mdpi.com mdpi.com/2076-3417/15/8/4161

Effectiveness of Photobiomodulation Therapy in the ... This study supports the use of photobiomodulation therapy as an adjunctive treatment for Fibromyalgia syndrome, promoting its integration into ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01782378

Scalp Application of LED Therapy to Improve Thinking and ... All LED devices were approved for use by the VABHS safety committee. Device 1. NIR, LED lined helmet (PhotoMedex, Horsham, PA or Thor Photomedicine, Inc., ...

7. thorlaser.com thorlaser.com/downloads/research/Cognition-and-Mood-research.pdf

Photobiomodulation (PBM) THOR Photomedicine ... Conclusion: NIR light treatment appears to be safe and potentially beneficial for AD patients. It improved cognitive function and activities of ...

8. nevadacancercoalition.org nevadacancercoalition.org/sites/default/files/2024-08/Asher%20CRCI%20Reno%20Aug%202024.pdf

2024 Nevada Cancer Summit Not for Redistribution Photobiomodulation. Pilot Study for CRCI. Not for Redistribution. Page 54. THOR LED Helmet ... • 30 cancer survivors with cancer-related cognitive impairment.