Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2;
α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo
patients bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and
hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III
trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 Gy (1.8Gy/d, 5
times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the
incidence of grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode
InGaAlP, 660nm-100mW-4J/cm²(DMC, São Carlos, São Paulo, Brazil). Oral mucositis evaluation
was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Incidence and / or severity of oral mucositis
The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.
Heliton S Antunes, DDS, MSc, PhD
Instituto Nacional de Cancer, Brazil
Brazil: Ministry of Health