Light Therapy for Oral Mucositis

Overseen By Ottawa Health Sciences Research Ethics Board

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Cetuximab

Disqualifiers: Photosensitive disorder, prior radiotherapy, 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: 4

25 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently receiving Cetuximab.

What data supports the effectiveness of the treatment for oral mucositis?

Research shows that photobiomodulation, including low-level laser therapy, is effective in reducing the severity and incidence of oral mucositis in cancer patients undergoing treatments like chemotherapy and radiotherapy. Studies have found that patients receiving this light therapy had better outcomes, with less severe mucositis compared to those who did not receive the treatment. ^{1 2 3 4 5}

Is light therapy safe for humans?

Research shows that light therapy, also known as photobiomodulation or low-level laser therapy, is generally safe for humans. Studies on its use for oral mucositis in cancer patients found no significant side effects or adverse events, indicating it is well-tolerated. ^{1 2 5 6 7}

How is photobiomodulation treatment different from other treatments for oral mucositis?

Photobiomodulation (light therapy) is unique because it uses low-level lasers or light to reduce pain and severity of oral mucositis, unlike other treatments that may involve medication or topical agents. It is non-invasive and works by promoting healing and reducing inflammation through light exposure, making it a novel option for patients undergoing cancer treatments. ^{1 2 4 6 8}

What is the purpose of this trial?

Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.

Eligibility Criteria

This trial is for adults over 18 with head and neck cancer who've had surgery without major remaining disease, can sign a consent form, and are in good physical condition. They're planning to receive radiotherapy or chemoradiotherapy. It's not for those with prior radiation in the area, visible mouth ulcers/infections, recent chemo within 3 months, photosensitivity disorders, or use of Cetuximab.

Inclusion Criteria

Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)

My mouth is healthy without sores or infections.

My oral cancer surgery removed all visible cancer, and there's no large lymph node cancer in the treatment area.

Exclusion Criteria

I have a skin condition that worsens with sunlight exposure.

I have had radiation therapy to my head or neck area.

I still have visible cancer after surgery in the area to be treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-radiotherapy Treatment

Participants receive one photobiomodulation treatment before starting radiotherapy

1 week

1 visit (in-person)

Radiotherapy with Photobiomodulation

Participants receive photobiomodulation treatments three times weekly during radiotherapy to prevent mucositis

6-7 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mucositis, pain, and quality of life

24 months

Treatment Details

Interventions

• Photobiomodulation

Trial Overview The trial tests Photobiomodulation (light therapy) as a preventive treatment against mucositis—painful mouth ulcers caused by radiotherapy—in patients with head and neck cancer. The light therapy will be applied before and during their standard radiotherapy treatments.

Participant Groups

Group I: Photobiomodulation Experimental Treatment 1 Intervention

Parameters: combined 633nm and 870 nm @1000mW * 1 Treatment pre radiotherapy * 3 treatments weekly during radiotherapy

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?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

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]

Low-level laser therapy (LLLT), also known as PhotoBioModulation (PBM), has strong evidence supporting its effectiveness in preventing and treating oral mucositis in patients undergoing radiotherapy for head and neck cancer or high-dose chemotherapy.

Recent advancements in LLLT/PBM technology and understanding of its mechanisms may allow it to manage a wider range of cancer treatment side effects, potentially improving patient adherence to therapy and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. Bensadoun, RJ.[2019]

In a study involving 80 pediatric patients with acute lymphoblastic leukemia undergoing high-dose methotrexate treatment, both low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) were found to have similar efficacy in preventing and treating oral mucositis, with incidence rates of 10% and 12.5%, respectively.

Both treatment groups took the same amount of time to resolve oral mucositis and pain, indicating that LEDT can be considered an effective alternative to LLLT for managing this condition in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. Guimaraes, DM., Ota, TMN., Da Silva, DAC., 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]

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 laser therapy (LLLT) significantly reduces the incidence and severity of oral mucositis (OM) in patients undergoing chemotherapy or radiotherapy for head and neck cancer, with effective doses ranging from 1 to 6 Joules per point.

Recent studies, including a meta-analysis of 11 randomized controlled trials with 415 patients, support LLLT as a promising treatment option, showing reduced pain and severity of OM without notable side effects, leading to recommendations for its use as a new standard of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy: a standard of supportive care for cancer therapy-induced oral mucositis in head and neck cancer patients? Jadaud, E., Bensadoun, R.[2021]

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) has been shown to be effective in both preventing and treating oral mucositis, a common side effect of cancer treatments, based on a systematic review and meta-analysis.

The analysis included multiple studies, indicating that LLLT can significantly reduce the severity and incidence of oral mucositis, suggesting it as a safe and beneficial intervention for patients undergoing chemotherapy or radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LOW-LEVEL LASER THERAPY MAY REDUCE THE RISK OF SEVERE ORAL MUCOSITIS IN PATIENTS RECEIVING CHEMOTHERAPY OR RADIOTHERAPY. Faggion, CM.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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

Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. [2019]

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

Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. [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

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

6. Japan pubmed.ncbi.nlm.nih.gov

Low-level laser therapy: a standard of supportive care for cancer therapy-induced oral mucositis in head and neck cancer patients? [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

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

LOW-LEVEL LASER THERAPY MAY REDUCE THE RISK OF SEVERE ORAL MUCOSITIS IN PATIENTS RECEIVING CHEMOTHERAPY OR RADIOTHERAPY. [2022]