Clinical Trial

Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

Study acronym: PBMOM-PEDMX
Not Yet Recruiting
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Summary
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J/cm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.
Trial Details
NCT Number NCT07372443
Lead Sponsor Universidad de Guanajuato
Conditions Oral Mucositis, Chemotherapy Effect, Pediatric Cancer
Enrollment 49 participants
Start Date 2026-01
Primary Completion 2027-01 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-28