Oral MucositisPBMNCT07387978
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
A study testing photobiomodulation in people with Oral Mucositis, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- photobiomodulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Nov 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sophie Beaumont, Bachelor of Dental surgery, 03 85596443, sophie.beaumont@petermac.org
Shae Beaton, Bachelor of oral health, 03 85596443, shae.beaton@petermac.org
About this study
Official title: 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.
Read the 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
- Conditions
- Oral Mucositis
- Being tested
- photobiomodulation
- Keywords
- photobiomodulation, low level laser therapy, head and neck cancer, oral cancer, radiotherapy, oral mucositis
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
photobiomodulation (low level laser therapy) application within and outside the oral cavity
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | 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. Receives: Device: photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start26 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387978
- Sponsor's protocol ID
- 25/131
- Acronym
- PBM
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a single institution study
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 JK, Mady LJ, Baddour K, Iheagwara UK, Zhai S, Ohr JP, Zandberg DP, Gorantla VC, Ferris RL, Kim S, Duvvuri U, Kubik MW, Sridharan S, Johnson JT, Holeva KD, Quinn AE, Clump DA. A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients. World J Otorhinolaryngol Head Neck Surg. 2022 Jul 14;8(4):345-354. doi: 10.1002/wjo2.18. eCollection 2022 Dec.
PubMed 36474663Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.
PubMed 29071801NICE. (2018). Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy.
Macann A, Fua T, Milross CG, Porceddu SV, Penniment M, Wratten C, Krawitz H, Poulsen M, Tang CI, Morton RP, Hay KD, Thomson V, Bell ML, King MT, Fraser-Browne CL, Hockey HU. 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. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):572-9. doi: 10.1016/j.ijrobp.2013.11.226.
PubMed 24521675Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
PubMed 32786044Courtois E, Bouleftour W, Guy JB, Louati S, Bensadoun RJ, Rodriguez-Lafrasse C, Magne N. Mechanisms of PhotoBioModulation (PBM) focused on oral mucositis prevention and treatment: a scoping review. BMC Oral Health. 2021 Apr 29;21(1):220. doi: 10.1186/s12903-021-01574-4.
PubMed 33926421Brandao TB, Morais-Faria K, Ribeiro ACP, Rivera C, Salvajoli JV, Lopes MA, Epstein JB, Arany PR, de Castro G Jr, Migliorati CA, Santos-Silva AR. Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. Support Care Cancer. 2018 Jul;26(7):2417-2423. doi: 10.1007/s00520-018-4046-z. Epub 2018 Feb 8.
PubMed 29423682Bensadoun RJ, Epstein JB, Nair RG, Barasch A, Raber-Durlacher JE, Migliorati C, Genot-Klastersky MT, Treister N, Arany P, Lodewijckx J, Robijns J; World Association for Laser Therapy (WALT). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer Med. 2020 Nov;9(22):8279-8300. doi: 10.1002/cam4.3582. Epub 2020 Oct 26.
PubMed 33107198
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07387978
- Acronym / sponsor ID
- PBM / 25/131
- Conditions
- Oral Mucositis
- Keywords
- photobiomodulation, low level laser therapy, head and neck cancer, oral cancer, radiotherapy, oral mucositis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: photobiomodulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photobiomodulationphotobiomodulation (low level laser therapy) application within and outside the oral cavity | Device | Photobiomodulation |
Primary outcome
Cumulative incidence and severity of acute oral mucositis
Time frame: Through study completion, an average of 1 year
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.
6 secondary outcomes
Function and quality of life (QoL)
Time frame: Through study completion, an average of 1 year
Pain in the oral cavity and throat
Time frame: Through study completion, an average of 1 year
Analgesia intake
Time frame: Through study completion, an average of 1 year
Need for enteral feeding
Time frame: Through study completion, an average of 1 year
Hospitalisation rates
Time frame: Through study completion, an average of 1 year
Trismus
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- BackgroundBensadoun, 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
- Background: PubMed 36474663Taylor JK, Mady LJ, Baddour K, Iheagwara UK, Zhai S, Ohr JP, Zandberg DP, Gorantla VC, Ferris RL, Kim S, Duvvuri U, Kubik MW, Sridharan S, Johnson JT, Holeva KD, Quinn AE, Clump DA. A phase Ⅱ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients. World J Otorhinolaryngol Head Neck Surg. 2022 Jul 14;8(4):345-354. doi: 10.1002/wjo2.18. eCollection 2022 Dec.
- Background: PubMed 29071801Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.
- BackgroundNICE. (2018). Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy.
- Background: PubMed 24521675Macann A, Fua T, Milross CG, Porceddu SV, Penniment M, Wratten C, Krawitz H, Poulsen M, Tang CI, Morton RP, Hay KD, Thomson V, Bell ML, King MT, Fraser-Browne CL, Hockey HU. 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. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):572-9. doi: 10.1016/j.ijrobp.2013.11.226.
- Background: PubMed 32786044Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
- Background: PubMed 33926421Courtois E, Bouleftour W, Guy JB, Louati S, Bensadoun RJ, Rodriguez-Lafrasse C, Magne N. Mechanisms of PhotoBioModulation (PBM) focused on oral mucositis prevention and treatment: a scoping review. BMC Oral Health. 2021 Apr 29;21(1):220. doi: 10.1186/s12903-021-01574-4.
- Background: PubMed 29423682Brandao TB, Morais-Faria K, Ribeiro ACP, Rivera C, Salvajoli JV, Lopes MA, Epstein JB, Arany PR, de Castro G Jr, Migliorati CA, Santos-Silva AR. Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. Support Care Cancer. 2018 Jul;26(7):2417-2423. doi: 10.1007/s00520-018-4046-z. Epub 2018 Feb 8.
- Background: PubMed 33107198Bensadoun RJ, Epstein JB, Nair RG, Barasch A, Raber-Durlacher JE, Migliorati C, Genot-Klastersky MT, Treister N, Arany P, Lodewijckx J, Robijns J; World Association for Laser Therapy (WALT). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer Med. 2020 Nov;9(22):8279-8300. doi: 10.1002/cam4.3582. Epub 2020 Oct 26.
- Individual participant dataSharing planned: No. This is a single institution study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation in people with Oral Mucositis, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Beaumont, Bachelor of Dental surgery (03 85596443, sophie.beaumont@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence and severity of acute oral mucositis (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07387978, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.