Transcranial Photobiomodulation for Childhood Cancer Survivorship

Overseen By Nicholas Phillips, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Stimulants

Disqualifiers: Low intelligence, Major psychiatric, Alcohol, Drug abuse, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking medication to treat neurocognitive impairment, you will need to stop, as the trial excludes participants on such medications.

Is transcranial photobiomodulation safe for humans?

Transcranial photobiomodulation (tPBM) is considered safe and non-invasive, as shown in studies involving healthy individuals and patients with conditions like breast cancer and Parkinson's disease. Research indicates it is generally well-tolerated with no significant side effects reported. ^{1 2 3 4 5}

How is transcranial photobiomodulation treatment different from other treatments for childhood cancer survivorship?

Transcranial photobiomodulation (tPBM) is unique because it uses non-invasive light therapy to stimulate brain activity, which is different from traditional cancer treatments that often involve drugs or surgery. This therapy involves applying near-infrared or red light to the scalp to activate neural tissues, offering a novel approach to potentially improve brain function in childhood cancer survivors. ^{3 4 5 6 7}

What is the purpose of this trial?

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning. Primary Objective To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL. Secondary Objectives To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL. Exploratory Objectives To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.

Research Team

Nicholas S Phillips, MD, PhD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for adults who had childhood cancer (ALL or HL), are now over 18, finished treatment at least 2 years ago, and have cognitive issues. They must speak English, have WiFi access, and not be on other cognitive trials or medications for neurocognitive impairment. Pregnant women and those with major psychiatric conditions, recent substance abuse, certain medical histories or low intelligence scores cannot join.

Inclusion Criteria

I was diagnosed before turning 21 and am enrolled in SJLIFE.

I finished treatment for ALL or Hodgkin's Lymphoma at SJCRH.

Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment

Exclusion Criteria

Major psychiatric condition

I am currently on medication for brain function issues.

Alcohol abuse in the past year (AUDIT) [greater than or equal to 13 for women and greater than or equal to 15 for men]

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) paired with cognitive training three days per week for a 2-month intervention period

8 weeks

Remote sessions

Follow-up

Participants are monitored for cognitive performance and self-reported outcomes after treatment

2 months

Treatment Details

Interventions

• Transcranial photobiomodulation (tPBM)

Trial Overview The study tests if a home-based Transcranial Photobiomodulation (tPBM) device paired with remote cognitive training can improve thinking skills in survivors of ALL and HL. It looks into how different tPBM frequencies affect cognition and self-reported symptoms like sleep quality and mood.

Participant Groups

Group I: sham tPBM + cognitive training Experimental Treatment 1 Intervention

Sham stimulations will act as the control for this study three days per week for a 2-month intervention period (5 ALL and 5 HL)

Group II: gamma tPBM + cognitive training Experimental Treatment 1 Intervention

three days per week for a 2-month intervention period (5 ALL and 5 HL)

Group III: alpha tPBM + cognitive training Experimental Treatment 1 Intervention

three days per week for a 2-month intervention period (5 ALL and 5 HL)

Transcranial photobiomodulation (tPBM) is already approved in United States, Canada for the following indications:

Approved in United States as Transcranial Photobiomodulation Therapy for:

• Oral mucositis resulting from cancer therapies

Approved in Canada as Transcranial Photobiomodulation Therapy for:

• Alzheimer's disease
• Major depression
• Generalized anxiety disorder

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

In a study of 120 breast cancer patients, photobiomodulation (PBM) therapy used to prevent acute radiation dermatitis showed no significant impact on disease-free survival (DFS), cancer-free survival (CFS), or overall survival (OS) compared to a placebo over a median follow-up of 66 months.

The findings suggest that PBM therapy is safe for oncologic patients, as it does not affect locoregional recurrence or the development of new primary tumors during conventional radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A long-term follow-up of early breast cancer patients treated with photobiomodulation during conventional fractionation radiotherapy in the prevention of acute radiation dermatitis. Robijns, J., Lodewijckx, J., Claes, M., et al.[2023]

Transcranial photobiomodulation (tPBM) is a safe and feasible treatment for Parkinson's disease, with only minor, temporary adverse events reported during a 12-week trial involving 20 participants.

While tPBM showed promise in reducing motor symptoms, there was no significant difference in motor scores between the active and sham treatment groups, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel transcranial photobiomodulation device to address motor signs of Parkinson's disease: a parallel randomised feasibility study. Herkes, G., McGee, C., Liebert, A., et al.[2023]

Photobiomodulation (PBM) therapy has shown moderate efficacy in preventing and managing side effects from radiation therapy, particularly for conditions like acute mucositis and upper limb lymphedema, based on randomized controlled trials.

While PBM could serve as supportive care for cancer patients undergoing various treatments, its long-term safety remains uncertain, necessitating cautious use and informed consent, especially in areas with known tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photobiomodulation in the prevention and the management of side effects of cancer treatments: Bases, results and perspectives]. Lairedj, K., Klausner, G., Robijns, J., et al.[2023]

Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that effectively enhances higher electrophysiological oscillations in the brain, based on a review of 10 studies involving healthy individuals aged 18-80.

While tPBM shows promise in improving brain activity, the evidence regarding its effects on lower oscillatory frequencies remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. Shetty, SJ., Shetty, S., Shettigar, D., et al.[2023]

In a study involving 101 children with severe chemotherapy-induced oral mucositis, laser photobiomodulation (PBM) significantly reduced the severity of mucositis, with 93.7% of PBM patients achieving a grade of less than 3 on the WHO scale by day 7 compared to 72% in the sham group (P = 0.01).

PBM also led to a significant reduction in pain levels on day 7, with a numeric pain rating scale score of 1 in the PBM group compared to 2.5 in the sham group (P < 0.006), and while there was a trend towards reduced analgesic use in the PBM group, it was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. Gobbo, M., Verzegnassi, F., Ronfani, L., et al.[2019]

In a study involving 20 individuals, those receiving near-infrared transcranial photobiomodulation (NIR t-PBM) showed a significant improvement in sexual function compared to those receiving sham therapy, indicating its potential efficacy for treating sexual dysfunction.

The improvements in sexual function were not linked to the antidepressant effects of t-PBM, suggesting that NIR t-PBM may have a distinct therapeutic action specifically for sexual dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. Cassano, P., Dording, C., Thomas, G., et al.[2020]

Transcranial photobiomodulation (tPBM) is a safe light therapy that uses non-ionizing radiation to target brain areas, showing potential efficacy in treating conditions like Alzheimer's disease, Parkinson's disease, and brain stroke.

While the current evidence for tPBM's effectiveness in neurodegenerative and vascular brain diseases is still limited, it is considered a promising adjuvant therapy based on experimental and clinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial photobiomodulation in therapy of neurodegenerative diseases of the brain: theoretical background and clinical effectiveness]. Belova, AN., Israelyan, YA., Sushin, VO., et al.[2021]

References

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

A long-term follow-up of early breast cancer patients treated with photobiomodulation during conventional fractionation radiotherapy in the prevention of acute radiation dermatitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A novel transcranial photobiomodulation device to address motor signs of Parkinson's disease: a parallel randomised feasibility study. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Photobiomodulation in the prevention and the management of side effects of cancer treatments: Bases, results and perspectives]. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]

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

Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT. [2019]

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

Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. [2020]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transcranial photobiomodulation in therapy of neurodegenerative diseases of the brain: theoretical background and clinical effectiveness]. [2021]