Purpose: Chemoradiotherapy (CRT)-induced oral mucositis (OM) adversely affects a patient's oral functions and quality of life (QOL). Low-level laser therapy (LLLT) showed some preventive and curative effects against clinically reported objective measures of OM in few trials including our recently published study. There is dearth of evidence regarding the effects of LLLT on patient's subjective experience of OM and QOL. Hence, we did this study to evaluate the effects of LLLT on a patient's reported measures of OM and QOL in head and neck cancer (HNC) patients receiving CRT. Methods: This triple blinded study randomized 220 HNC patients scheduled for CRT (three weekly Cisplatin + RT = 66 Gray (2 Gy/session), five fractions/week for 6.5 weeks, total 33 fractions) into laser (110) and placebo (110) groups. The laser group received LLLT (Technomed Electronics Advanced Laser Therapy 1000, He-Ne, λ = 632.8 nm, power density = 24 mW/cm2, dosage = 3.0 J at each point, total dose/session = 36-40 J, spot size 1 cm2, irradiation time/point 125 s) before each radiation session, while the placebo group did not receive laser therapy. Methodology was similar to our recently published study (Gautam et al. Radiother Oncol 104:349-354, 2012). In this part of our study, a blinded assessor collected subjective outcomes of the patient's reported measures of OM using Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN) and QOL using Functional Assessment of Cancer Treatment-Head and Neck (FACT-HN) Questionnaire. Data were analyzed using repeated measure ANOVA through general linear model. Statistical significance was kept at p < 0.05. Results: Results analysis revealed that OMWQ-HN (F = 12.199, df = 6,1314, p < 0.001) and FACT-HN (p < 0.05) scores were significantly lower in LLLT than placebo group patients. Also, a significant reduction (p < 0.001) in incidence of severe OM, need for opioid analgesics, and total parenteral nutrition was observed. Conclusions: LLLT was effective in improving the patient's subjective experience of OM and QOL in HNC patients receiving CRT.
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