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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether photobiomodulation therapy, a type of light treatment, can safely and effectively aid individuals with oral Graft-Versus-Host Disease (GVHD). GVHD may occur after a stem cell transplant, causing the immune system to attack the mouth's tissues. The study will compare a treatment group receiving light therapy to a placebo group. Suitable candidates include those who have undergone a stem cell transplant, experience persistent mouth problems despite other treatments, and have maintained stable medications for the past two weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in GVHD care.

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 prior data suggests that photobiomodulation therapy is safe for oral Graft-Versus-Host Disease?

Research has shown that photobiomodulation (PBM) therapy is generally safe for people. In one study, patients with oral Graft-Versus-Host Disease (GVHD) who received PBM therapy experienced less pain within a week and showed healing in their mouths within two weeks. Another study found that PBM therapy is safe and might even extend patients' lives.

Reports indicate that PBM therapy is well-tolerated, with no serious side effects noted in the available studies. This suggests that PBM therapy could be a low-risk option for treating oral GVHD, although individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Photobiomodulation Therapy for oral graft-versus-host disease because it offers a unique approach compared to typical treatments like immunosuppressive drugs. Unlike these standard options, which primarily aim to suppress the immune response, Photobiomodulation Therapy uses light to stimulate cell repair and reduce inflammation directly in the affected tissues. This non-invasive method has the potential to provide relief with fewer side effects and can be used alongside existing therapies to enhance overall treatment effectiveness. By targeting the cellular processes, it represents a promising new avenue for managing this challenging condition.

What evidence suggests that photobiomodulation therapy might be an effective treatment for oral GVHD?

This trial will compare photobiomodulation therapy to a placebo sham device for treating oral Graft-Versus-Host Disease (GVHD). Research has shown that photobiomodulation therapy, also known as low-level laser therapy, may help treat oral GVHD. In one study, 130 out of 153 cases showed positive results for oral and dental issues with this therapy. Another study found that patients with oral GVHD experienced symptom relief and improved function after receiving photobiomodulation therapy. Additionally, several reports indicate that this treatment helped manage long-term oral GVHD. Overall, early evidence suggests that photobiomodulation therapy could effectively relieve symptoms of oral GVHD. ^{1 2 3 6 7}

Who Is on the Research Team?

Alina K Markova, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27655559/

Photobiomodulation therapy in the management of chronic ... We report seven cases of oral cGVHD that were treated with photobiomodulation therapy (PBM), previously known as low-level laser therapy (LLLT).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05675930

A Study of Photobiomodulation (PBM) Therapy in People ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100020302039

Photobiomodulation and antimicrobial photodynamic ... The present study aimed to report a clinical case in which oral CMV reactivation following acute GVHD was treated by a combination of aPDT and PBMT ...

4. liebertpub.com liebertpub.com/doi/10.1089/pho.2023.0153

The Application of PBM Therapy in Patients Subjected to ... Conclusions: The efficacy of PBM in oral GVHD has been demonstrated through symptom alleviation and function improvement. It is recommended as an adjuvant ...

5. withpower.com withpower.com/trial/phase-2-graft-vs-host-disease-11-2022-c5d11

Photobiomodulation Therapy for Oral Graft-Versus-Host ... Low level light/laser therapy (LLLT) shows promise for treating oral and dental disorders, with 130 out of 153 reviewed studies reporting positive effects ...

6. astctjournal.org astctjournal.org/article/S1083-8791(18)31077-2/pdf

Photobiomodulation (PBM) Provides a Prompt and Near- ... Improvement in pain scale was observed. 1 week after starting therapy and healing of the oral cavity was observed at 2 weeks. This non-IS treatment appears ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666741/

Safety and efficacy of photobiomodulation therapy in ... A significant and growing literature indicates that PBMT is safe and effective, and may even offer a benefit in patient overall survival.