Research AppraisalRandomised Controlled Trial

Photobiomodulation for oral mucositis in cancer care: prevention, clinical management, and evidence from randomized controlled trials.

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in CancerParra-Rojas, Susell, Cassol-Spanemberg, Juliana, Pérez, Alejandra Navarro et al.19 June 2026DOI

Clinical Snapshot

45CEBM
Evidence: WeakRandomised Controlled Trial

PICO Framework

P — PopulationAdult cancer patients (≥18 years) undergoing cancer treatment (chemotherapy, radiotherapy, or haematopoietic stem cell transplantation) at risk of or experiencing oral mucositis
I — InterventionPhotobiomodulation (PBM; low-level laser/light therapy) — intraoral or extraoral, preventive or therapeutic protocols
C — ComparatorSham PBM intervention (placebo light device) or no PBM control
O — OutcomesIncidence and severity of oral mucositis (primary); pain intensity, analgesic requirements, nutritional support needs, and related clinical outcomes (secondary)

Bottom Line

This PROSPERO-registered systematic review of 15 sham-controlled RCTs (868 adult patients) provides narrative evidence that photobiomodulation (PBM) reduces the incidence and severity of oral mucositis, pain intensity, analgesic requirements, and nutritional support needs in adult cancer patients. Preventive intraoral protocols appear most consistently beneficial. However, the review's clinical utility is substantially constrained by the absence of meta-analytic pooling, no GRADE certainty assessment, undisclosed risk-of-bias methodology, and significant protocol heterogeneity across included trials. No pooled effect sizes or confidence intervals are reported, making it impossible to quantify the magnitude of benefit with precision. Single-institution authorship from a phototherapy-focused research group introduces potential confirmation bias. For Australian clinicians, PBM remains a reasonable supportive care option in tertiary oncology settings with trained operators, consistent with existing MASCC/ISOO guidance for haematopoietic stem cell transplantation. This review reinforces the biological plausibility and directional benefit of PBM but does not provide sufficient quantitative rigour to mandate protocol adoption or inform PBS/TGA submissions. High-quality, multi-centre RCTs with standardised PBM parameters and GRADE-assessed outcomes are urgently needed.

Evidence: Weak

Key Findings

  • P Value: Not reported at the systematic review level; individual trial p-values not synthesised.

  • Effect Size: Not reported — no pooled effect size (risk ratio, odds ratio, or mean difference) was calculated. Results are presented narratively only.

  • Primary Outcome: Most of the 15 included RCTs (868 adult patients) reported reductions in severe oral mucositis incidence with PBM compared to sham control. Preventive intraoral PBM protocols were associated with more favourable outcomes than therapeutic protocols.

  • Nnt Or Sensitivity: NNT not calculable from available data. No sensitivity or subgroup analyses reported. Reductions in pain intensity, analgesic requirements, and nutritional support needs were described qualitatively across most included trials.

  • Confidence Interval: Not reported — no confidence intervals provided for any outcome.

Clinical Application

PBM devices are available in specialist oncology dental and oral medicine units. Intraoral delivery requires trained operators and appropriate laser/LED equipment. Protocol standardisation remains a barrier to widespread implementation. Cost, access, and operator training are practical constraints, particularly in regional and rural Australian settings. The intervention is non-pharmacological, non-invasive, and generally well-tolerated, supporting feasibility in tertiary cancer centres. Oral mucositis is a significant and costly complication of cancer treatment in Australia, affecting quality of life and treatment adherence. The Multinational Association of Supportive Care in Cancer (MASCC) and International Society of Oral Oncology (ISOO) guidelines, which inform Australian oncology practice, have previously recommended low-level laser therapy for OM prevention in haematopoietic stem cell transplantation settings. PBM devices used for this indication are not currently PBS-listed, and TGA regulatory status varies by device class. RACGP and oncology nursing guidelines do not yet provide specific PBM protocol recommendations. Australian cancer centres with oral medicine or maxillofacial units may already offer PBM; however, equitable access across public hospital networks remains limited. This review supports the existing MASCC/ISOO evidence base but does not provide sufficient new quantitative data to prompt immediate PBS or TGA policy change. Adult cancer patients undergoing chemotherapy, radiotherapy (particularly head and neck cancer), or haematopoietic stem cell transplantation who are at risk of or experiencing oral mucositis. The evidence base appears strongest for preventive intraoral PBM protocols in this population.

Abstract

PURPOSE: This systematic review aimed to evaluate the efficacy of photobiomodulation (PBM) for the prevention and clinical management of oral mucositis (OM) in adult cancer patients, with particular emphasis on protocol characteristics potentially associated with favorable clinical outcomes. METHODS: A systematic search of PubMed, Web of Science, and Scopus was conducted up to March 31, 2026, in accordance with PRISMA guidelines. Randomized controlled trials in adult cancer patients comparing PBM with sham interventions were included. Outcomes of interest included OM incidence, severity, pain, and related clinical outcomes. The review protocol was prospectively registered in PROSPERO. RESULTS: Fifteen randomized controlled trials involving 868 adult patients were included. Most studies reported favorable effects of PBM, including reductions in severe OM incidence, pain intensity, analgesic requirements, and nutritional support needs compared with controls. Preventive intraoral PBM protocols were generally associated with more favorable outcomes, although variability in treatment parameters, delivery methods, and outcome reporting limited comparability. Most included studies demonstrated acceptable methodological quality. CONCLUSIONS: PBM appears to be a promising supportive care intervention for reducing the burden of OM in adult cancer patients, particularly in preventive settings. However, variability across protocols precludes definitive conclusions regarding optimal treatment parameters. Further high-quality randomized trials with standardized reporting are needed to refine protocol recommendations and expand evidence in therapeutic settings.

References

  1. 1.Parra-Rojas, S., Cassol-Spanemberg, J., Pérez, A. N., Baggio, G. L., & Velázquez-Cayón, R. T. (2026). Photobiomodulation for oral mucositis in cancer care: prevention, clinical management, and evidence from randomized controlled trials. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer. https://doi.org/10.1590/pboci.2024.012
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