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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство photobiomodulation
  photobiomodulation (low level laser therapy) application within and outside the oral cavity

Первичные конечные точки

• Cumulative incidence and severity of acute oral mucositis [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (6)

• Function and quality of life (QoL) [Срок оценки: Through study completion, an average of 1 year]
• Pain in the oral cavity and throat [Срок оценки: Through study completion, an average of 1 year]
• Analgesia intake [Срок оценки: Through study completion, an average of 1 year]
• Need for enteral feeding [Срок оценки: Through study completion, an average of 1 year]
• Hospitalisation rates [Срок оценки: Through study completion, an average of 1 year]
• Trismus [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австралия · 1 центр

• Peter MacCallum Cancer Centre — Melbourne

Публикации

• 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,
• 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 PMID 36474663
• 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. PMID 29071801
• NICE. (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 PMID 24521675
• 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. PMID 32786044
• 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. PMID 33926421
• 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 F PMID 29423682

Идентификаторы

NCT: NCT07387978 · 25/131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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