Comparable efficacy of extraoral and intraoral photobiomodulation in preventing oral mucositis during high-dose methotrexate therapy in pediatric oncology: A single-blind randomized controlled trial
In brief
Extraoral light therapy matched intraoral treatment for mouth sores in children
In this randomized trial of 155 children receiving high-dose methotrexate, mouth sores occurred in 30.5% with extraoral treatment and 41.1% with intraoral treatment, a difference that was not statistically significant; severity and pain also did not differ. Extraoral sessions took 30 seconds versus about 6 minutes, but the trial did not establish that the approaches are equivalent.
- Journal
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Q1)
- Published
- 19 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Isabela de Oliveira Plugge Freitas, Isabela Schuartz, Giovanna Leal Klein Renz, Rafael Zancan Mobile, Mariana Lena Sassi França, Mara Albonei Dudeque Pianovski, et al.
- PMID
- 42897331
- DOI
- 10.1007/s00520-026-11372-9
Why clinicians should know about it
- Picked for Hematology (top studies of the week, 1 November 2026): Randomized mucositis prevention trial includes leukaemia and lymphoma chemotherapy
Abstract
PURPOSE: This prospective randomized controlled clinical study compared intraoral (IO) and extraoral (EO) photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in pediatric oncology patients. METHODS: A total of 155 patients (1-18 years), receiving high-dose methotrexate (HDMTX) for leukemia, lymphoma, or osteosarcoma, were randomized to PBM-IO (n = 73) or PBM-EO (n = 82). Preventive PBM was administered daily from hospital admission through discharge. Both protocols used red light with equivalent dosimetry (660 nm, 100 mW, 1 J per point). PBM-EO required 30 s/session, whereas PBM-IO required approximately 6 min, excluding patient handling time. OM occurrence, severity (WHO scale), plaque index, and pain (numeric rating scale) were assessed on days 0, 3, 5, and 10 after HDMTX infusion. RESULTS: The overall OM occurrence was 35.5%, with no significant difference between PBM-IO (41.1%) and PBM-EO (30.5%) groups (p = 0.168). No statistically significant differences were observed between groups for OM severity, pain, salivary pH, or plaque index at any time point (p > 0.05). Multivariable ordinal logistic regression demonstrated that PBM modality was not independently associated with OM severity. As expected, increasing age (OR = 1.14; 95% CI: 1.04-1.25; p = 0.004) and higher HDMTX dose (OR = 1.24; 95% CI: 1.03-1.49; p = 0.021) were significantly associated with greater OM severity. Median pain scores remained 0 at all assessment points in both groups. CONCLUSION: Extraoral PBM demonstrated comparable effectiveness to intraoral for OM prevention in pediatric patients undergoing HDMTX chemotherapy, while reducing application time.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.