Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients - A triple blinded randomized controlled trial

Background and purpose: Oral mucositis (OM) is most cumbersome acute side effect of concurrent chemoradiotherapy (CCRT) for head and neck cancer (HNC). OM associated pain affects oral functions and nutrition of the patient that may result in discontinuity of treatment. Several modalities have been tried to prevent and treat OM, but none proved completely successful until date. We used prophylactic low level laser therapy (LLLT) for the prevention and treatment of CCRT induced OM. Materials and methods: In this triple blinded study, 221 HNC patients scheduled to undergo CCRT (Cisplatin (1, 22, 43 day) + RT = 66 Grays (2 Gy/fraction), 33 fractions, 5 fractions/week, for 45 days) were block randomized into laser (n = 111) and placebo (n = 110) group. Laser group received LLLT (HeNe, λ = 632.8 nm, power-density = 24 mW, dosage = 3.0 J/point, total dosage/session = 36-40 J, spot-size = 1 cm², 5 sessions/week) while placebo received sham treatment daily prior to radiation. OM (RTOG/EORTC Scale), oral pain (VAS), dysphagia (FIS), weight loss and CCRT break were assessed. Data were analyzed using frequencies and percentage, generalized estimating equations (GEE) and odds ratio. Results: There was significant reduction in incidence of severe OM (F = 16.64, df = 8876, p < 0.0001) and its associated pain (F = 25.06, df = 8876, p < 0.0001), dysphagia (F = 20.17, df = 8876, p < 0.0001) and opioid analgesics use (p < 0.0001) in laser than placebo group patients. Conclusions: LLLT decreased the incidence of CCRT induced severe OM and its associated pain, dysphagia and opioid analgesics use.