Gouvea de Lima, A., Villar, R.C., de Castro, G., Jr., Antequera, R., Gil, E., Rosalmeida, M.C., … Snitcovsky, I.M.L. (2012). Oral mucositis prevention by low-level laser therapy in head-and-neck cancer patients undergoing concurrent chemoradiotherapy: A phase III randomized study. International Journal of Radiation Oncology, Biology, Physics, 82, 270–275.

To evaluate the efficacy of low-level laser therapy (LLLT) to decrease severe oral mucositis and reduce radiation therapy (RT) interruptions

 Patients received either gallium aluminum arsenide LLLT 2.5 J/cm² or placebo laser before each radiation fraction.

• The study reported on 75 patients with a median age of 55 years.
• The sample was 76% male and 24% female. 
• Patients had head and neck cancer, which was primarily squamous cell carcinoma.
• All patients underwent conventionally fractionated RT s-GY daily fractions, five times per week.

This was a single-site, outpatient study conducted in Brazil.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, phase III study.

• The National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2, was used.
• A visual analog scale was used.

• Appearance of grade 3 mucositis was delayed in the patients treated with LLLT.
• Unplanned RT interruptions because of severe mucositis were necessary for six patients in the placebo arm and none in the LLLT arm.
• Pain scores and analgesic medication use were similar in the two arms.
• No significant differences were found between groups.

LLLT benefit was limited to fewer interruptions in RT.

• The sample size was small with fewer than 100 patients.
• Another dosage or a specific type of LLLT may be more effective.

LLLT dosage, schedule, specific laser type, and availability all need to be addressed.