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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist childhood cancer survivors who face cognitive challenges due to past treatment. It uses transcranial photobiomodulation (tPBM), a light therapy applied to the head, combined with at-home cognitive training exercises. The researchers aim to determine if tPBM can enhance attention, memory, and other cognitive skills, while also alleviating symptoms like sleep problems and anxiety. Individuals who have completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL) and experience cognitive difficulties may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that may improve survivors' quality of life.

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.

What prior data suggests that transcranial photobiomodulation is safe for childhood cancer survivors?

Research has shown that transcranial photobiomodulation (tPBM) is generally safe for people. tPBM is a light therapy using a type of light energy that does not harm the brain. Studies have found it well-tolerated in both adults and children. For instance, research on children aged 2-6 years suggested that tPBM might be safe and helpful for conditions like autism spectrum disorder, indicating potential for other uses as well.

When focusing on alpha and gamma tPBM, both types use light to target specific brain areas and improve their function. Studies have not reported any major negative side effects with these treatments, which is a positive sign for their safety.

Moreover, testing tPBM in a clinical trial for childhood cancer survivors, who are considered a vulnerable group, suggests it is seen as relatively safe. However, like any treatment, monitoring for side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial photobiomodulation (tPBM) for childhood cancer survivors because it offers a non-invasive approach to potentially improve brain function. Unlike traditional treatments that might involve medication or surgery, tPBM uses light to stimulate brain activity, which could enhance cognitive recovery without the side effects often associated with drugs. Another unique aspect is the incorporation of cognitive training alongside tPBM, which might strengthen the treatment's effectiveness. This innovative combination could provide a safer and more holistic option for improving quality of life in survivors of childhood cancer.

What evidence suggests that transcranial photobiomodulation could be effective for improving cognitive performance in childhood cancer survivors?

Research has shown that transcranial photobiomodulation (tPBM) might improve thinking skills like memory and decision-making. In this trial, participants will receive either alpha tPBM, gamma tPBM, or sham tPBM, each combined with cognitive training. Studies have found that tPBM can help manage thinking problems caused by treatments such as radiation therapy. This treatment also appears to reduce anxiety and depression, which can affect cognitive function. tPBM is generally considered safe and is being further studied for its potential benefits in various conditions affecting thinking. While more research is needed, these early results are promising for those facing cognitive challenges after surviving childhood cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Nicholas S Phillips, MD, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/transcranial-photobiomodulation-for-childhood-cancer-survivorship-23658

Transcranial Photobiomodulation for Childhood Cancer ... 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 ...

2. careacross.com careacross.com/clinical-trials/trial/NCT05550948

Use of Transcranial Photobiomodulation to Improve ... Trial Title: Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer. NCT ID: NCT05550948.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1221193/full

Transcranial photobiomodulation in children aged 2–6 years These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9945713/

Advances in photobiomodulation for cognitive improvement by ... This review addresses the mechanisms of photobiomodulation on neurons and neural networks and discusses the advantages, disadvantages and potential ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06555-3

The effectiveness of Transcranial Photobiomodulation therapy ... tPBMT led to significant improvements in anxiety, depression, and opioid craving among individuals in MMT, and these improvements were sustained at one month ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497671/

Safety of 810 nm photobiomodulation in the developing brain We explored safety of PBM (810 nm) in young male Wistar rats by examining astrocytes and microglia cells thought GFAP and Iba1 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04668001

Transcranial Photobiomodulation With Near-Infrared Light ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...