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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether light therapy, or photobiomodulation, can prevent and treat painful mouth sores in children with cancer. The focus is on children undergoing specific cancer treatments, such as high-dose chemotherapy or radiation for head and neck cancers, which often cause mouth sores, known as mucositis. Researchers will compare children who receive light therapy to those who do not, to determine its effectiveness in reducing pain and sores. Eligible participants have been diagnosed with specific types of cancer and are currently receiving treatment in a hospital setting. Participants will report their pain levels, have their mouths photographed, and receive light therapy every other day while hospitalized. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from an innovative treatment while contributing to valuable research.

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 prior data suggests that light therapy is safe for children with cancer?

Research has shown that light therapy, also known as photobiomodulation, is generally safe for treating mouth sores. Studies have found it can help with oral health issues like mucositis, painful mouth sores caused by cancer treatments. This therapy uses low-level lasers or LED lights to reduce pain and speed up healing.

Some research indicates that this light therapy is safe and effective for people undergoing cancer treatment. One study found that low-level laser therapy for mouth sores is necessary and does not cause major side effects. However, the long-term safety of this treatment is still under investigation, especially regarding its effects on cancer treatment outcomes.

Overall, current evidence suggests that light therapy is a safe option for reducing the severity of mouth sores in people with cancer. Clinical trial participants are closely monitored to ensure proper management of any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation for treating mouth sores because it offers a non-invasive alternative to current options like topical analgesics or oral rinses. Unlike these traditional treatments, which primarily aim to manage pain, photobiomodulation uses light to promote healing at the cellular level, potentially reducing healing time. This innovative approach could not only alleviate discomfort more quickly but also enhance the overall recovery of the affected tissues.

What evidence suggests that light therapy is effective for mouth sores in children with cancer?

This trial will compare the effects of light therapy, also known as photobiomodulation, on mouth sores with a retrospective review of patients who did not receive this therapy. Studies have shown that photobiomodulation effectively treats mouth sores, especially those caused by cancer treatments like chemotherapy. Research indicates that this therapy can greatly reduce pain and improve patients' quality of life. One study found that light therapy lessened the severity of oral mucositis, painful mouth sores from cancer treatments. Another study suggested that using this therapy beforehand could help prevent these sores from developing. Overall, light therapy appears to be a promising option for managing mouth sores in cancer patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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 (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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1011134425000181

Effectiveness of Photobiomodulation (low-level laser ... The study demonstrates that Photobiomodulation is a more effective and efficient method for reducing pain, tingling, and improving quality of life in both the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7409159/

Photobiomodulation Therapy in Oral Mucositis and ... Photobiomodulation therapy (PBMT) is an effective treatment modality, which has the significant advantage of enhancing a patient's quality of life (QoL)

3. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-05579-1

Photobiomodulation preconditioning for oral mucositis ... This trial aims to study the effect of preconditioning with photobiomodulation in preventing oral mucositis and xerostomia in cancer patients undergoing ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10456364/

Low-Level Laser Therapy for the Treatment of Oral ... Conclusions: The application of laser therapy results in decreased severity of oral mucositis from radiation and chemotherapy. Our study shows ...

5. mdpi.com mdpi.com/2227-9059/12/10/2366

Assessing the Cost-Effectiveness of Photobiomodulation ... Numerous studies found that low-level laser therapy is cost-effective and efficient compared to other symptomatic treatments and provides a better quality of ...

6. ada.org ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/practice/dental-standards/aip-review/189_aip_11_23.pdf

PHOTOBIOMODULATION (PBM) IN ORAL HEALTH A major emphasis is to outline the advances in the mechanistic insights and clinical dosing that are enabling the safe and effective utilization of this therapy ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06071637

Low Power Laser Therapy As Prevention Of Oral Mucositis ... The WHO mucositis assessment scale consists of: grade 0, the patient does not have ulcers or erythema in the oral mucosa; grade 1, the patient does not have ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2212440325009654

LED-based low-level light therapy for oral mucositis in ... This systematic review aimed to evaluate the efficacy of light-emitting diode (LED) therapy in reducing oral mucositis (OM) severity, pain, and healing time in ...

9. aetna.com aetna.com/cpb/medical/data/300_399/0363.html

Cold Laser and High-Power Laser Therapies Aetna considers low-level laser therapy medically necessary for prevention of oral mucositis in persons undergoing cancer treatment associated with ...