Light Therapy for Mouth Sores

(PBM Trial)

Overseen By Peter Shaw, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Unwilling to participate, 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: Up to 2 years

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding light therapy to your existing treatment.

What data supports the effectiveness of the treatment for mouth sores?

Research shows that light therapy, also known as photobiomodulation, can help heal mouth sores by reducing inflammation and pain. Studies have found it effective in treating oral mucositis, a common side effect in cancer patients, and it has shown positive effects in healing tissues and reducing inflammation in dental treatments. ^{1 2 3 4 5}

Is light therapy safe for treating mouth sores?

Research shows that light therapy, also known as photobiomodulation, is generally safe for use in humans, with no significant side effects reported in studies involving oral conditions like mucositis and other oral diseases. ^{1 2 6 7 8}

How is light therapy different from other treatments for mouth sores?

Light therapy, or photobiomodulation, is unique because it uses low-level light to stimulate cell responses, promoting healing and reducing inflammation without side effects. Unlike other treatments, it is noninvasive, painless, and can be safely used by patients, including those with compromised health, such as cancer patients. ^{1 2 5 7 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are: Is it reasonable and acceptable to provide light therapy for children with cancer? Does light therapy prevent and treat mouth sores related to medical treatment? Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis. Participants will: * Tell the nurse their pain score, related to their mouth sores, before receiving light therapy. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.

Eligibility Criteria

This trial is for children with cancer who are experiencing or at risk of developing mouth sores, known as mucositis. To participate, they must be hospitalized on the cancer unit or an alternate unit and able to communicate their pain levels.

Inclusion Criteria

I can speak and understand either English or Spanish.

I am currently admitted to a cancer care, intensive care, or other acute care unit.

I have a specific cancer type and am receiving certain treatments.

Exclusion Criteria

Do not meet eligibility criteria outline above

I am not willing to participate in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive light therapy every other day while admitted to the hospital to prevent and treat mouth sores

Up to 2 years

Every other day (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Photobiomodulation

Trial Overview The study is testing light therapy (photobiomodulation) to see if it can prevent or treat mouth sores in these children. It involves comparing kids who haven't had light therapy before with those receiving it during the trial.

Participant Groups

Group I: Retrospective Arm Active Control 1 Intervention

Retrospective data review of patients who did not receive light therapy

Group II: Prospective Arm Active Control 1 Intervention

Prospective data review of patients who receive light therapy

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

Approved in European Union as Photobiomodulation for:

• Prevention of radiation-induced oral mucositis in head and neck cancer patients

Approved in Canada as Photobiomodulation for:

• Prevention of radiation-induced oral mucositis in head and neck cancer patients (under clinical trial evaluation)

Approved in United States as Photobiomodulation for:

• Prevention of radiation-induced oral mucositis in head and neck cancer patients (recommended in international guidelines)

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

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/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]

Photobiomodulation (PBM) therapy is recommended for the prevention of oral mucositis (OM) in cancer patients undergoing specific treatments, such as hematopoietic stem cell transplantation and head and neck radiotherapy, based on a systematic review of the literature.

Currently, there is insufficient evidence to provide guidelines for the treatment of established OM or chemotherapy-related OM, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Zadik, Y., Arany, PR., Fregnani, ER., et al.[2021]

Photobiomodulation is effective in reducing the severity of oral mucositis, as shown in a systematic review of 6 studies involving 299 patients, where the laser treatment group had a greater chance of improvement compared to the control group.

While photobiomodulation showed promise in reducing oral mucositis severity, the analysis of its effects on the duration of lesions and pain reduction was inconclusive due to high variability among the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of photobiomodulation in the treatment of oral mucositis in patients undergoing antineoplastic therapy: systematic review and meta-analysis. Cruz, AR., Minicucci, EM., Betini, M., et al.[2023]

High-power laser photobiomodulation (PBM) therapy significantly reduced pain in 25 cancer patients with refractory oral mucositis, with 94% of treatment sessions resulting in immediate pain relief.

Patients experienced an average pain reduction of 72% for chemotherapy-induced mucositis and 60% for radiotherapy-induced mucositis, with effects lasting around 6 days, indicating PBM as a safe and effective non-drug option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. Finfter, O., Cohen, R., Hanut, A., et al.[2023]

In a study of 26 patients with oral squamous cell carcinoma undergoing treatment, low-level laser therapy (LLLT) significantly reduced the incidence and severity of oral mucositis, with 72.7% of the LLLT group achieving normal mucosa by week 5 compared to only 20% in the control group.

The study found no significant differences in side effects or medication use between the LLLT and control groups, indicating that LLLT is a safe intervention for managing mucositis during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. Marín-Conde, F., Castellanos-Cosano, L., Pachón-Ibañez, J., et al.[2019]

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]

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

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

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of photobiomodulation in the treatment of oral mucositis in patients undergoing antineoplastic therapy: systematic review and meta-analysis. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. [2019]

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

Photobiomodulation Therapy in Oral Medicine: A Guide for the Practitioner with Focus on New Possible Protocols. [2020]

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

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

9. Poland pubmed.ncbi.nlm.nih.gov

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