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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photobiomodulation | Device | photobiomodulation (low level laser therapy) application within and outside the oral cavity |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Beaumont, Bachelor of Dental surgery | Contact | 03 85596443 | sophie.beaumont@petermac.org | |
| Shae Beaton, Bachelor of oral health | Contact | 03 85596443 | shae.beaton@petermac.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 36474663 |
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This is a single institution study
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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 |
| Background |
| 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. |
| 29071801 | Background | Sroussi 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. |
| Background | NICE. (2018). Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy. |
| 24521675 | Background | 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. |
| 32786044 | Background | Elad 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. |
| 33926421 | Background | Courtois 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. |
| 29423682 | Background | Brandao 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. |
| 33107198 | Background | Bensadoun 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. |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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