Effects of low-level laser therapy in the prevention and treatment of concurrent chemoradiotherapy induced oral mucositis: A triple-blind randomized controlled trial.

5526 Background: Oral mucositis (OM) is the most cumbersome acute side effect of concurrent chemoradiotherapy (CCRT) for head and neck cancer (HNC). OM associated pain affects oral function also may lead to CCRT break. Several modalities have been tried to prevent and treat this complication but none has been proved successful till date. We used prophylactic Low Level Laser Therapy (LLLT) for the prevention and treatment of CCRT induced OM. Methods: In this triple blind study, 221 HNC patients scheduled to undergo CCRT were randomized into laser (n=111) and placebo (n=110) group. Laser group received LLLT (Helium Neon laser, λ=632.8nm, P=24m, W=3.0J/cm2) while placebo received sham treatment daily prior to radiation for 45days. Oral Mucositis (OM) (RTOG/EORTC Scale), oral pain (Visual Analog Scale - VAS), dysphagia (Functional Impairment Scale - FIS), weight loss, duration of analgesic use were assessed. Data was 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, degree of freedom df=8,876, p<0.0001) and its associated pain (F=25.06, df=8,876, p<0.0001) and dysphagia (F=20.17, df=8,876, p<0.0001) and loss of weight (F=87.56, df=8,876, p<0.0001) when compared between the Laser and placebo group. The duration of step III analgesia required was also significantly lower (p<0.001) in laser (3.2 ±1.4days) than placebo (6.7 ±2.6days) group. Conclusions: LLLT was able to decrease the incidence of CCRT induced severe OM its associated pain, dysphagia, weight loss and the duration of analgesic use. [Table: see text]