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
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 (Presented at SPIE BiOS: January 28, 2017; Published: 17 February 2017); https://doi.org/10.1117/12.2256528.
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