Photobiomodulation Therapy for Oral Graft-Versus-Host Disease

Recruiting at 11 trial locations

Overseen By Doris Ponce, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Uncontrolled infection, Head/neck cancer, Pregnant, others

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not change your systemic immunosuppressive therapy within 2 weeks before joining the study, and if you're using oral topical treatments, you should be stable on them for at least 2 weeks before enrolling and can continue them during the study.

What data supports the effectiveness of the treatment Photobiomodulation Therapy for Oral Graft-Versus-Host Disease?

Research shows that Photobiomodulation Therapy, also known as Low-Level Laser Therapy, has positive effects on healing and reducing inflammation in periodontal and dental implant procedures, as well as promoting tissue repair and pain relief in wound healing and chronic pain management. ^{1 2 3 4 5}

Is Photobiomodulation Therapy generally safe for humans?

Photobiomodulation Therapy, also known as Low-Level Laser Therapy (LLLT), is generally considered safe and is used to promote healing, reduce inflammation, and relieve pain. However, there is some concern that it might activate precancerous cells or increase existing cancerous tissue, so more research is needed to fully understand its safety in all situations. ^{1 2 3 5 6}

How is Photobiomodulation Therapy different from other treatments for oral graft-versus-host disease?

Photobiomodulation Therapy is unique because it uses light to stimulate natural healing processes in the body, reducing inflammation and pain without the use of drugs. This non-invasive treatment is different from traditional methods as it directly targets cells to promote healing and reduce symptoms. ^{2 4 5 6 7}

Research Team

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for people aged 4 or older with oral Graft-Versus-Host Disease after a stem cell transplant. They must have an NIH-modified OMRS score of at least 3, failed one line of therapy like topical corticosteroids, and been stable on any current oral treatments for two weeks. Pregnant or breastfeeding individuals, those with uncontrolled infections, or unable to follow the study plan are excluded.

Inclusion Criteria

I am 4 years old or older.

I haven't changed my immunosuppressive medication in the last 2 weeks.

I have severe oral complications from a transplant and treatments haven't worked.

Exclusion Criteria

I had mucosal head or neck cancer within the last 5 years.

Pregnant or breastfeeding

Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation therapy or placebo for oral Graft-Versus-Host Disease

4 weeks

Weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Photobiomodulation Therapy
• Placebo sham device

Trial Overview The study tests if Photobiomodulation (PBM) Therapy using the Thor LX2.3 system can safely and effectively treat oral GVHD compared to a placebo sham device. Participants will be randomly assigned to receive either PBM therapy or a sham treatment as part of the research.

Participant Groups

Group I: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT) Active Control 1 Intervention

Participants are Allo-HCT recipients

Group II: Adult and pediatric patients who received a placebo treatment Placebo Group 1 Intervention

Participants are Allo-HCT recipients

Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in European Union as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low-level light therapy (LLLT) shows promising benefits in periodontal and dental implant treatments, demonstrating biostimulatory, anti-inflammatory, and analgesic effects that can enhance healing and reduce inflammation.

Despite the positive findings, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based protocols for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level light therapy (photobiomodulation) shows promising benefits in periodontal and dental implant treatments, including enhanced healing and reduced inflammation, based on a review of various studies.

Despite the positive effects observed, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based treatment protocols for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low level light/laser therapy (LLLT) shows promise for treating oral and dental disorders, with 130 out of 153 reviewed studies reporting positive effects such as pain relief and faster healing.

LLLT is considered a safe and novel approach for oral applications, suggesting it could address unmet clinical needs in dental care, although its use in this area has been limited compared to other medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. Carroll, JD., Milward, MR., Cooper, PR., et al.[2022]

Low level laser therapy (LLLT) can increase the proliferation of cancer cells, as shown in a study using osteosarcoma and lung carcinoma cell lines, indicating potential risks when used in dental treatments.

The study found that the proliferation rates of cancer cells increased with both the power output of the laser and the number of applications, suggesting that LLLT could inadvertently activate precancerous cells or exacerbate existing cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. Kara, C., Selamet, H., Gökmenoğlu, C., et al.[2022]

In a study involving 138 patients with recurrent aphthous stomatitis (RAS), Nd:YAG laser therapy significantly reduced pain and lesion size compared to a placebo, demonstrating its efficacy in managing RAS lesions.

Both focused and defocused laser techniques were effective, with focused laser providing a higher energy density, suggesting that laser parameters can be adjusted for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of recurrent aphthous ulcers with therapeutic Nd:YAG laser, using two different methods. Fekrazad, R., Gholami, GA., Sadr Eshkevari, P., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015]

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

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. [2020]

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

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. [2020]

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

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. [2022]

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

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Management of recurrent aphthous ulcers with therapeutic Nd:YAG laser, using two different methods. [2023]