Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial.

PURPOSE: The purpose of this study is to evaluate the effectiveness of low-level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation.
METHODS: This is a randomized, parallel, superiority trial including 35 patients divided into the following: laser (n = 17) and sham (n = 18). The variables assessed were oral mucositis (grade 2 of the World Health Organization oral toxicity scale), severe oral mucositis (grade 3 or 4), and pain (according to a visual analogue scale). In the laser group, a InGaAlP laser, wavelength of 650 nm, power 100 mW, energy per point of 2 J, time 20 s by point, extremity fiber optic 0.028 cm(2), and energy density 70 J/cm(2), was used, applied the first day of conditioning until D + 5, while the sham group received simulated laser over the same period.
RESULTS: No statistically significant difference was found in the incidence of oral mucositis (p = 0.146). Severe mucositis was found in 40% of the patients (14/35), 3 in the intervention group (17.65%) and 11 in the sham group (61.11%) (p = 0.015). The cumulative probability of survival with respect to the development of severe oral mucositis was >0.6 for the intervention group and 0 for the control group (p = 0.0397). On the day on which pain was considered the worst, patients in the sham group were more likely to classify their pain as severe compared to those in the laser group (p = 0.041).
CONCLUSION: Low-level laser therapy proved effective for the prevention of severe oral mucositis and intense oral pain in patients submitted to hematopoietic stem cell transplantation.

RCT Entities:   Population Interventions Outcomes