Photobiomodulation Therapy for Oral Graft-Versus-Host Disease

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Alina K Markova, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

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

Prior Safety Data

Approved in 3 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Westchester (Consent only) Harrison, NY

Memorial Sloan Kettering Monmouth (Consent only) Middletown, NJ

Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, NY

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) Uniondale, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

References

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

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015] Low level laser therapy (LLLT) is a therapeutic method which regulates the biological behavior of cells with light. The effects of LLLT consist of promotion of tissue repair, inhibition of inflammation, and relief of pain by promoting or inhibiting the cell proliferation, increasing or decreasing the release of some bioactive substances. Therefore, LLLT is also known as photomodulation. At present, there are many relevant experimental studies of LLLT abroad, and they are also used clinically. This article reviews the effect of LLLT on wound healing.

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

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. [2020] (Part 2 of this article can be located at www.liebertpub.com/doi/10.1089/photob.2019.4731.) Objective: Finding evidence-based treatment strategies for low-level light therapy (LLLT) and the correct incorporation of these treatment methods in the clinical practice of periodontics. Background: Photobiomodulation has been shown to have biostimulatory, anti-inflammatory and analgesic effects that can be beneficial in periodontal and dental implant treatment procedures. Methods: In this review we have addressed some clinical questions regarding the potential clinical application of low-level light irradiation and its photobiomodulatory effects in periodontology and implantology. The literature was searched for in vivo (animal or clinical) articles written in English in four electronic databases of PubMed, Scopus, Google Scholar, and Cochrane Library until April 2019. Only studies with low irradiation doses without any thermal effects used only for their photobiomodulatory purposes were included. Results: We were able to find relevant studies for all of our questions, and positive effects for the application of light therapy were reported in most of the studies. However, there is still great deal of heterogeneity in terms of study designs and most importantly in light irradiation devices and the parameters used. Owing to this issue it was not possible to reach specific evidence-based irradiation protocols for the questions addressed in this review. Conclusions: Based on our search results, an obvious positive effect of LLLT on stimulation of healing of periodontal soft and hard tissues and reduction of inflammation can be seen. Future well-designed randomized control studies with the same irradiation settings and systematic reviews evaluating the studies found on the questions mentioned are necessary to reach evidence-based recommendations.

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

Photobiomodulation in Periodontology and Implant Dentistry: Part 2. [2020] (Part 1 of this article can be located at www.liebertpub.com/doi/10.1089/photob.2019.4710.) Objective: Finding evidence-based treatment strategies for low-level light therapy and the correct incorporation of these treatment methods in the clinical practice of periodontics. Background: Photobiomodulation has been shown to have biostimulatory, anti-inflammatory, and analgesic effects that can be beneficial in periodontal and dental implant treatment procedures. Methods: In this review, we have addressed some clinical questions regarding the potential clinical application of low-level light irradiation and its photobobiomodulatory effects in periodontology and implantology. The literature was searched for in vivo (animal or clinical) articles written in English in four electronic databases of PubMed, Scopus, Google Scholar, and Cochrane Library until April 2019. Only studies with low irradiation doses without any thermal effects used only for their photobiomodulatory purposes were included. Results: We were able to find relevant studies for all of our questions, and positive effects for the application of light therapy were reported in most of the studies. However, there is still a great deal of heterogeneity in terms of study designs and most importantly in light irradiation devices and the parameters used. Due to this issue, it was not possible to reach specific evidence-based irradiation protocols for the questions addressed in this review. Conclusions: Based on our search results, an obvious positive effect of low-level light therapy on stimulation of healing of periodontal soft and hard tissues and reduction of inflammation can be seen. Future well-designed randomized control studies with the same irradiation settings and systematic reviews evaluating the studies found on the questions mentioned are necessary to reach evidence-based recommendations.

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] Low-level laser therapy (LLLT) is a form of light therapy that triggers biochemical changes within cells. Photons are absorbed by cellular photoreceptors, triggering chemical alterations and potential biochemical benefits to the human body. LLLT has been used in pain management for years and is also known as cold laser therapy, which uses low-frequency continuous laser of typically 600 to 1000 nm wavelength for pain reduction and healing stimulation. Many studies have demonstrated analgesic and anti-inflammatory effects provided by photobiomodulation in both experimental and clinical trials.

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

Developments in low level light therapy (LLLT) for dentistry. [2022] Low level light/laser therapy (LLLT) is the direct application of light to stimulate cell responses (photobiomodulation) in order to promote tissue healing, reduce inflammation and induce analgesia. There have been significant studies demonstrating its application and efficacy at many sites within the body and for treatment of a range of musculoskeletal injuries, degenerative diseases and dysfunction, however, its use on oral tissues has, to date, been limited. The purpose of this review is to consider the potential for LLLT in dental and oral applications by providing background information on its mechanism of action and delivery parameters and by drawing parallels with its treatment use in analogous cells and tissues from other sites of the body.

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

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. [2022] Low level laser therapy (LLLT), which stimulates natural biological processes in the application region, is frequently used in dental treatments. The aim of our study was to evaluate the effects of LLLT which could activate precancerous cells or increase existing cancerous tissue in case of clinically undetectable situations.

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

Management of recurrent aphthous ulcers with therapeutic Nd:YAG laser, using two different methods. [2023] Low-level laser therapy (LLLT) has been applied for the management of craniomaxillofacial disorders, including intraoral wounds, as well as recurrent aphthous stomatitis (RAS) lesions. However, the proper combination of laser features and tissue characteristics remains the major challenge in the realm of photobiomodulation (PBM).