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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single site, pilot randomized, double blinded control trial designed to assess changes in cognitive symptoms in cancer survivors with cancer-related cognitive impairment. Patients will be randomized into one of two Arms: Intervention or Control. * Arm A: Intervention Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'therapeutic setting', 35mW/cm2 = 42J/cm2 * Arm B: Control Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'placebo setting', 0mW/cm2 = 0J/cm2 This study has been designed to assess the hypothesis that Photobiomodulation can have a positive impact on cognitive symptoms in cancer survivors with cancer-related cognitive impairment. 30 participants will be recruited for this study, 15 per group. Self-report questionnaires assessing cognitive concerns, cognitive abilities, quality of life, depression, and anxiety will be administered at three timepoints through the study Baseline, End of Study Visit and 1 Month Follow Up

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.

Is photobiomodulation therapy safe for humans?

Research shows that photobiomodulation therapy (PBMT) is generally safe for humans, with studies indicating no adverse effects in both cancer patients and healthy individuals. It has been used safely in various conditions, including brain disorders and cancer-related complications. ^{1 2 3 4 5}

How does the THOR LED Photobiomodulation Helmet treatment differ from other treatments for cancer-related cognitive impairment?

The THOR LED Photobiomodulation Helmet is unique because it uses red or near-infrared light to stimulate and protect brain tissue, which is different from traditional drug-based treatments. This non-invasive approach may improve cognitive function by promoting brain health and reducing inflammation, offering a novel option for those with cancer-related cognitive impairment. ^{2 5 6 7 8}

Research Team

Arash Asher, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

I finished my cancer treatment between 6 months and 5 years ago, but I may still be on certain maintenance therapies.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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

Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

4. Ireland pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial). [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Photobiomodulation Promotes Hippocampal Neurogenesis and Improves Cognitive Function and Anti-Inflammatory Injury in Rats With Chronic Cerebral Hypoperfusion]. [2023]

6. United States 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. [2022]

7. United States 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. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Epidural photobiomodulation accelerates the drainage of brain interstitial fluid and its mechanism]. [2022]