Oral mucositis prevention by low-level laser therapy in head and neck cancer patients submitted to concurrent chemoradiation: A prospective randomized study

6019 Background: Oral mucositis is a major treatment-related complication of concurrent chemoradiation (CRT) in head and neck cancer (HNC) patients (pts), affecting nutrition, pain control, quality of life and adequate treatment delivery. Low level laser (LLL) is a promising preventive therapy. We aimed to evaluate the efficacy of LLL to decrease and delay severe oral mucositis and its impact on RT interruptions. Methods: In this prospective, randomized, double-blind, phase III trial, pts were treated with either daily He-Ne LLL 2.5 J/cm2, or placebo laser, before RT. Eligible pts had to be diagnosed with SCC or undifferentiated carcinoma of oral cavity, pharynx, larynx, or metastatic to the neck with unknown primary site (UPS); age > 18 y; candidates to adjuvant or definitive CRT; signed informed consent. CRT consisted of conventional RT 60–70 Gy (1.8–2.0 Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were oral mucositis severity in wks 2, 4 and 6 (CTC-NCI v.2.0); RT interruptions due to mucositis; pain intensity (VAS). To detect a decrease in the incidence of grade 3 or 4 oral mucositis from 80 to 50%, we planned to enroll 74 pts, error I/II 5 and 20%, respectively. Results: 73 pts were included (77% male; mean age 53 y); primary site: oropharynx (31 pts), larynx (15), nasopharynx (10), hypopharynx (8), oral cavity (7 pts), UPS (2); 36 pts received prophylactic LLL. Mean delivered RT dose (Gy) was higher in pts treated with LLL (69.3 vs. 67.8, p = 0.04). The number of treatment fields was the same (6 vs. 6, p = 0.50) and the mean cisplatin dose-intensity was 40.9 and 40.1 mg/m2/wk (p = 0.3) between pts treated with LLL or placebo, respectively. During CRT, the number of pts diagnosed with grade 3 or 4 oral mucositis treated with LLL/placebo was 4/5 (wk 2, p = 1.0); 4/11 (wk 4, p = 0.08); and 8/9 (wk 6, p = 1.0), respectively. More pts treated with placebo had RT interruptions due to mucositis (6 vs. 0, p =0.02). The occurrence of severe pain did not differ between the study arms in wks 2, 4 and 6 (5/5, 8/8 and 8/8, p = 1.0). Conclusions: LLL therapy was effective in reducing grade 3 or 4 oral mucositis and in reducing RT interruptions in these HNC pts treated with concurrent CRT, which may translate into improved CRT efficacy and tolerance. No significant financial relationships to disclose.