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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests light therapy, or photobiomodulation, to determine if it can reduce painful mouth ulcers caused by radiotherapy for head and neck cancer. Previous studies in Europe have suggested its potential effectiveness, but it is not yet used in Canada. The trial will apply light therapy before and during radiotherapy to assess its safety and effectiveness. Individuals who have undergone surgery for head and neck cancer, with no remaining disease, and are scheduled for radiotherapy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore a potentially beneficial treatment not yet available in Canada.

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 prior data suggests that this light therapy is safe for reducing oral mucositis in head and neck cancer patients?

Research has shown that photobiomodulation, or light therapy, safely and effectively reduces the severity and pain of mouth sores in patients undergoing treatment for head and neck cancer. Studies have found that this therapy not only lessens mouth sores but also improves quality of life compared to treatments like mouthwash.

Although researchers continue to study the long-term safety of this therapy, current evidence suggests it is well-tolerated. Notably, patients using this treatment have reported no significant immediate or late side effects. International guidelines already recommend this therapy, and its widespread use in Europe supports its credibility as a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photobiomodulation is unique because it uses light at specific wavelengths (633nm and 870nm) to treat oral mucositis, a painful condition often caused by cancer treatments like radiotherapy. Unlike standard care options, which might involve pain management and protective coatings, this treatment works by stimulating cellular repair and reducing inflammation directly through light therapy. Researchers are excited about this approach because it offers a non-invasive, targeted way to potentially speed up healing and reduce discomfort without the side effects associated with traditional medications.

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

Research has shown that light therapy, or photobiomodulation, effectively reduces painful mouth ulcers in patients receiving radiation for head and neck cancer. Studies have found that this therapy eases the pain and severity of these ulcers more effectively than some other treatments, such as mouthwash. It also improves the quality of life for patients experiencing these side effects. Although not yet common in Canada, international guidelines recommend this therapy, and it is already widely used in Europe. This positive evidence suggests that light therapy, which participants in this trial will receive, could be a promising option for managing mouth ulcers in cancer patients. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06071637

Low Power Laser Therapy As Prevention Of Oral Mucositis ... Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493773/

Reviewing the efficiency of photobiomodulation therapy in ... The aim of the present systematic review is to evaluate the effects of different photobiomodulation therapy (PBMT) approaches in oncological treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03972527

Study Details | NCT03972527 | Photobiomodulation to ... The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce ...

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

Effectiveness of Photobiomodulation (low-level laser ... Photobiomodulation reduces oral mucositis severity and pain. •. Photobiomodulation shows superior improvement in quality of life versus mouthwash treatment. •.

5. 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 ...

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

Photobiomodulation Therapy in Oral Mucositis and ... The long-term safety of low-level laser therapy, and its potential impact on tumour response, are still subject to testing. The randomized controlled trails ...

7. 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 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34021422/

Long-term safety of photobiomodulation therapy for oral ... The aim of this study was to investigate if different PBMT protocols for OM control have association with immediate and late adverse effects in HCT patients.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04671862

NCT04671862 | Photobiomodulation for the Prevention of ... Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated ...