Light Therapy for Oral Mucositis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must not be taking: Cetuximab
Disqualifiers: Photosensitive disorder, prior radiotherapy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12567How 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.
12468Eligibility 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.
+3 more
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.
+2 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: PhotobiomodulationExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ottawa HospitalOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. [2021]To systematically review the literature and update the evidence-based clinical practice guidelines for the use of photobiomodulation (PBM), such as laser and other light therapies, for the prevention and/or treatment of oral mucositis (OM).
Photobiomodulation or low-level laser therapy in the management of cancer therapy-induced mucositis, dermatitis and lymphedema. [2019]There is a large body of evidence supporting the efficacy of low-level laser therapy (LLLT) also known as PhotoBioModulation (PBM) when used for the prevention and/or treatment of oral mucositis in patients undergoing radiotherapy for head and neck cancer, or high-dose chemotherapy regimens. This review aims at giving the state of the art of this technique in this indication.
Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. [2021]The objective of the present study was to compare the efficacy of photobiomodulation with low-level laser therapy (LLLT) or light-emitting diode therapy (LEDT) devices for the prevention and treatment of oral mucositis in pediatric patients diagnosed with acute lymphoblastic leukemia undergoing chemotherapy with high doses of methotrexate (MTX).
Efficacy of photobiomodulation in the treatment of oral mucositis in patients undergoing antineoplastic therapy: systematic review and meta-analysis. [2023]To evaluate the effectiveness of photobiomodulation in the treatment of oral mucositis.
Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial. [2019]The objective of this study was to assess the effectiveness of photobiomodulation with low-level laser therapy (LLLT) as a preventive and therapeutic procedure for the treatment of oral and oropharyngeal mucositis caused by radio-chemotherapy in patients diagnosed with oral squamous cell carcinoma (SCC). An experimental, prospective, double-blind, randomized controlled study was conducted involving patients diagnosed with oral SCC undergoing oncological treatment. The variables analyzed included grade, appearance, and remission of mucositis. A final sample of 26 patients was included: 11 (42.3%) in the study group and 15 (57.7%) in the control group; their average age was 60.89±9.99years. Statistically significant differences between the groups were observed from week 5 of oncological treatment; 72.7% of the laser group showed normal mucosa (mucositis grade 0), while in the control group, 20.0% showed grade 0 mucositis and 40.0% showed grade 2 mucositis (P0.05). The tolerance evaluation did not show any statistically significant difference between the groups regarding the occurrence of side effects or adverse events during the trial (P>0.05). Photobiomodulation with LLLT reduces the incidence and severity of mucositis in patients treated with radiotherapy±chemotherapy.
Low-level laser therapy: a standard of supportive care for cancer therapy-induced oral mucositis in head and neck cancer patients? [2021]Oral mucositis (OM) is still a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It may affect quality of life, require supportive care and impact treatment planning and its efficacy. Low-level laser therapy (LLLT) seems to promote pain relief and reduces OM incidence and its severity. It has been recommended for these patients as a treatment option but without any consensus in the LLLT procedure. New recommendations and perspectives for clinical trials will be discussed. Materials (Subjects) and Methods: Step by step, the efficacy of soft laser in the management of iatrogenic oral mucositis has been evaluated during the last two decades. Its effectiveness and level of recommendation got stronger with time. We will report and discuss some major results and the latest recommendations published on this topic.
Developments in low level light therapy (LLLT) for dentistry. [2022]Low level light/laser therapy (LLLT) is the direct application of light to stimulate cell responses (photobiomodulation) in order to promote tissue healing, reduce inflammation and induce analgesia. There have been significant studies demonstrating its application and efficacy at many sites within the body and for treatment of a range of musculoskeletal injuries, degenerative diseases and dysfunction, however, its use on oral tissues has, to date, been limited. The purpose of this review is to consider the potential for LLLT in dental and oral applications by providing background information on its mechanism of action and delivery parameters and by drawing parallels with its treatment use in analogous cells and tissues from other sites of the body.
LOW-LEVEL LASER THERAPY MAY REDUCE THE RISK OF SEVERE ORAL MUCOSITIS IN PATIENTS RECEIVING CHEMOTHERAPY OR RADIOTHERAPY. [2022]Peng et al. Low-level laser therapy in the prevention and treatment of oral mucositis: a systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Oct;130(4):387-397.e9. doi: 10.1016/j.oooo.2020.05.014. Epub 2020 Jun 5.