LBA5524 Background: Oral mucositis (OM) remains a limiting factor in in head and neck squamous cell carcinomas (HNSCC) patients (pts) treated with chemoradiation (CRT) leading to pain, dysphagia, and weight loss. Low-level laser therapy (LLLT) emerges as a promising, preventive therapy of CRT-induced OM. Yet, a definitive randomized trial supporting its use is lacking. This study was designed to assess the efficacy of LLLT in reducing the incidence and/or severity of OM. Methods: Assuming OM grade (G3) for placebo 0.4 (P0); LLLT 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 LLLT and 47 placebo pts bearer of HNSCC of nasopharynx, oropharynx and hipopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional RT 70.2 Gy (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were OM incidence and severity, RT interruptions due to OM and pain intensity. The LLLT used daily was a diode InGaAlP (660nm-100mW-4J/cm²). OM evaluation was done by WHO and OMAS scale. Results: Mean age was 54.6 and 87.2% of pts were male. Primary site: oropharynx (74 pts), nasopharynx (9 pts), hypopharynx (11 pts). In the LLLT arm the incidence of OM G 3/4 was only 6.4% versus 48% in the placebo arm; HR of 0.13 (IC 95%, p<0.001). Besides in the LLLT arm 51% of pts did not have ulcers versus 17% in placebo arm (p<0.001). LLLT pts had less severe pain (p=0.012), used less narcotic analgesic, HR 0.33 (IC 95%, p<0.001) and required less gastrostomia, HR 0.037 (IC 95%, p= 0.005). No LLLT pts had RT interrupted due to OM. EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 were applied. Results clearly favored the LLLT arm. In QLQ-C30 benefit was seen in both physical and emotional functioning (p=0.037), fatigue (p=0.011), pain (p=0.043); and in QLQ-H&N35, pain (p=0.007), swallowing (p=0.001) and trouble with social eating (p=0.026). Conclusions: Our results indicate that upfront LLLT in HNSCC pts submitted to CRT is an effective tool in reducing G 3/4 OM, oral pain, use of narcotic and gastrostomia. QoL data supports the efficacy findings. Thereby LLLT should be the new standard of care in this setting.
Effect of Prophylactic Low Level Laser Therapy on Oral Mucositis: A Systematic Review and Meta-Analysis
