A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment (PBM)

A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment

The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy.

Participants will receive PBM treatment five times a week throughout the course of their radiotherapy.

The main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: photobiomodulation

Detailed Description

BACKGROUND: Strong evidence exists within the literature regarding the effectiveness and safety of PBM in preventing oral mucositis in head and neck cancer patients. PBM is recommended in the Multinational Association of Supportive Care in Cancer and National Institute of Health and Care Excellence oral mucositis prevention guidelines, as a treatment modality for oral mucositis prevention in H&N cancer patients. PBM using the THOR laser has received TGA approval for use in prevention and treatment of oral mucositis in Australia.

PARTICIPANTS: post operative oral cancer patients, with clear margins, planned for radiotherapy (50Gy or greater) +/- chemotherapy.

METHODS: participants will receive PBM treatment five times a week throughout the course of their radiotherapy.

EXPECTED OUTCOMES: decrease in incidence and severity of oral mucositis, decrease in pain levels and improved quality of life, less need for analgesia, increased ability to maintain oral intake, less severe trismus, lower rates of hospitalization

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Beaumont, Bachelor of Dental surgery; Phone Number: 03 85596443; Email: sophie.beaumont@petermac.org
• Study Contact Backup: Name: Shae Beaton, Bachelor of oral health; Phone Number: 03 85596443; Email: shae.beaton@petermac.org

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
      • Contact: Sophie Beaumont, Bachelor of Dental surgery; Phone Number: 03 85596443; Email: sophie.beaumont@petermac.org
      • Contact: Shae Beaton, Bachelor of oral health; Phone Number: 03 85596443; Email: shae.beaton@petermac.org
      • Principal Investigator: Sophie Beaumont, Bachelor of Dental Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient has provided written informed consent using the PBM PICF
• Age ≥ 18 years of age at Screening
• Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area
• Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)
• Intact oral mucosa (no visible ulceration, dehiscence, or active infection)

Exclusion Criteria:

• Gross macroscopic and/or microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
• Prior RT to the head and neck including the oral or oropharyngeal mucosa
• Prior cytotoxic chemotherapy in the last 3 months
• Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
• Concurrent administration of cetuximab
• Known to be pregnant or planning to become pregnant within the trial period
• Diagnosis of epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Photobiomodulation; Participants will receive photobiomodulation therapy five times a week during the course of their radiation treatment. Upon completion of radiotherapy, if oral mucositis is still present, participants can choose to continue photobiomodulation treatment until oral mucositis has resolved. The frequency of photobiomodulation will be conducted at the discretion of the investigator.

Device: photobiomodulation; photobiomodulation (low level laser therapy) application within and outside the oral cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence and severity of acute oral mucositis	To describe the effect of PBM on the cumulative incidence and severity of acute OM as defined by the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) for radiation induced mucositis during RT and for 8 weeks following RT.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function and quality of life (QoL)	Quantitative analysis of MD Anderson Symptom Inventory for Head and Neck Cancer scores to describe the effect of PBM on function and QoL	Through study completion, an average of 1 year
Pain in the oral cavity and throat	Quantitative analysis of Oral Mucositis Weekly Questionnaire-Head and Neck scores to describe effect of PBM on oral cavity and throat pain	Through study completion, an average of 1 year
Analgesia intake	Concurrent use of analgesic medications and mouthwashes to determine effect of PBM on need for analgesia (yes/no)	Through study completion, an average of 1 year
Need for enteral feeding	Use of enteral feeding to describe effect of PBM on ability to maintain oral intake	Through study completion, an average of 1 year
Hospitalisation rates	Hospitalisation rates due to mucositis in the oral cavity or related events will be documented	Through study completion, an average of 1 year
Trismus	Maximal-interincisal opening. For participants who are edentulous, the distance from the edentulous ridge to the opposing side vertically will be used instead	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peter MacCallum Cancer Centre, Australia

Publications and helpful links

General Publications

• Bensadoun, R. J., Epstein, J. B., Nair, R. G., Barasch, A., Raber-Durlacher, J. E., Migliorati, C., Genot-Klastersky, M. T., Treister, N., Arany, P., & Lodewijckx, J. (2020). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer medicine, 9(22), 8279-8300. Brandão, T. B., Morais-Faria, K., Ribeiro, A. C. P., Rivera, C., Salvajoli, J. V., Lopes, M. A., Epstein, J. B., Arany, P. R., de Castro, G., & Migliorati, C. A. (2018). Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. Supportive Care in Cancer, 26, 2417-2423. Courtois, E., Bouleftour, W., Guy, J. B., Louati, S., Bensadoun, R. J., Rodriguez-Lafrasse, C., & Magné, N. (2021). Mechanisms of PhotoBioModulation (PBM) focused on oral mucositis prevention and treatment: a scoping review. BMC Oral Health, 21(1), 220. Elad, S., Cheng, K. K. F., Lalla, R. V., Yarom, N., Hong, C., Logan, R. M., Bowen, J., Gibson, R., Saunders, D. P., & Zadik, Y. (2020). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer, 126(19), 4423-4431. Macann, A., Fua, T., Milross, C. G., Porceddu, S. V., Penniment, M., Wratten, C., Krawitz, H., Poulsen, M., Tang, C. I., & Morton, R. P. (2014). Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer: first report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study. International Journal of Radiation Oncology* Biology* Physics, 88(3), 572-579. NICE. (2018). Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy. Sroussi, H. Y., Epstein, J. B., Bensadoun, R. J., Saunders, D. P., Lalla, R. V., Migliorati, C. A., Heaivilin, N., & Zumsteg, Z. S. (2017). Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva cha
• Taylor, J. K.-A., Mady, L. J., Baddour, K., Iheagwara, U. K., Zhai, S., Ohr, J. P., Zandberg, D. P., Gorantla, V. C., Ferris, R. L., & Kim, S. (2022). A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients. World Journal of Otorhinolaryngology-Head and Neck Surgery, 8(04), 345-354.
• Sroussi, H. Y., Epstein, J. B., Bensadoun, R. J., Saunders, D. P., Lalla, R. V., Migliorati, C. A., Heaivilin, N., & Zumsteg, Z. S. (2017). Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer medicine, 6(12), 2918-2931
• NICE. (2018). Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy.
• Macann, A., Fua, T., Milross, C. G., Porceddu, S. V., Penniment, M., Wratten, C., Krawitz, H., Poulsen, M., Tang, C. I., & Morton, R. P. (2014). Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer: first report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study. International Journal of Radiation Oncology* Biology* Physics, 88(3), 572-579
• Elad, S., Cheng, K. K. F., Lalla, R. V., Yarom, N., Hong, C., Logan, R. M., Bowen, J., Gibson, R., Saunders, D. P., & Zadik, Y. (2020). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer, 126(19), 4423-4431.
• Courtois, E., Bouleftour, W., Guy, J. B., Louati, S., Bensadoun, R. J., Rodriguez-Lafrasse, C., & Magné, N. (2021). Mechanisms of PhotoBioModulation (PBM) focused on oral mucositis prevention and treatment: a scoping review. BMC Oral Health, 21(1), 220.
• Brandão, T. B., Morais-Faria, K., Ribeiro, A. C. P., Rivera, C., Salvajoli, J. V., Lopes, M. A., Epstein, J. B., Arany, P. R., de Castro, G., & Migliorati, C. A. (2018). Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. Supportive Care in Cancer, 26, 2417-2423.
• Bensadoun, R. J., Epstein, J. B., Nair, R. G., Barasch, A., Raber-Durlacher, J. E., Migliorati, C., Genot-Klastersky, M. T., Treister, N., Arany, P., & Lodewijckx, J. (2020). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer medicine, 9(22), 8279-8300.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: radiotherapy; head and neck cancer; oral cancer; low level laser therapy; photobiomodulation; oral mucositis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Stomatitis; Mouth Neoplasms; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 25/131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a single institution study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes