Extraorally delivered photobiomodulation therapy for prevention of oropharyngeal mucositis in pediatric patients undergoing hematopoietic cell transplantation

Christine N. Duncan; Anna N. Yaroslavsky; Wendy B. London; Amy F. Juliano; Stephen T. Sonis; Ather Adnan; Nathaniel S. Treister

doi:10.1117/12.2256528

17 February 2017 Extraorally delivered photobiomodulation therapy for prevention of oropharyngeal mucositis in pediatric patients undergoing hematopoietic cell transplantation

Christine N. Duncan, Anna N. Yaroslavsky, Wendy B. London, Amy F. Juliano, Stephen T. Sonis, Ather Adnan, Nathaniel S. Treister

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Proceedings Volume 10048, Mechanisms of Photobiomodulation Therapy XII; 1004807 (2017) https://doi.org/10.1117/12.2256528
Event: SPIE BiOS, 2017, San Francisco, California, United States

Abstract

Background: Oral mucositis (OM) is a painful consequence of myeloablative hematopoietic cell transplantation (HCT). Extraorally delivered photobiomodulation therapy (PBMT) is a promising novel intervention for the prevention of OM in children. Objectives: With funding from an NIDCR R34 planning grant, the objectives of this study are 1) to model the dosimetry of external PBMT and the optimal device parameters for the planned clinical trial, and 2) to plan and design a placebo-controlled Phase 2 multicenter clinical trial to determine whether extraorally delivered PBMT can reduce the duration of severe OM in children, with intent for implementation under subsequent U01 funding. Methods: External PBMT dosimetry will be evaluated using pediatric head and neck MRI studies to obtain serial measurements of different tissues that will then be used to develop a sophisticated computational model. We plan to conduct a placebocontrolled Phase 2 multicenter clinical trial in which patients 4 to 21 years of age will be randomized 1:1:1 to receive external PBMT dose 1x, external PBMT dose 2x, or sham PBMT starting from conditioning, daily until day +20 post- HCT. Significance: Extraorally delivered PBMT is a feasible, potentially efficacious intervention that could improve the quality of life for all children undergoing myeloablative HCT. The planned Phase 2 study, based on rigorous dose modeling and with detailed attention to uniform delivery of therapy and OM assessments, will provide critical efficacy data and the potential basis for a subsequent definitive Phase 3 trial. Grant Support: NIDCR R34 DE025908-01

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Christine N. Duncan, Anna N. Yaroslavsky, Wendy B. London, Amy F. Juliano, Stephen T. Sonis, Ather Adnan, and Nathaniel S. Treister "Extraorally delivered photobiomodulation therapy for prevention of oropharyngeal mucositis in pediatric patients undergoing hematopoietic cell transplantation", Proc. SPIE 10048, Mechanisms of Photobiomodulation Therapy XII, 1004807 (17 February 2017); https://doi.org/10.1117/12.2256528

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