AbstractBackground and Objective:
Every patient receiving radiotherapy experience increasing inflammation of the irradiated mucosa with the progress of treatment. This is especially true in curative treatment regimens. Hence the present study was undertaken with the objective to evaluate the therapeutic effect of low-level helium neon laser therapy in the management of concurrent chemoradiotherapy induced mucositis in Oral and Oro-pharyngeal cancer patients.
Methodology: This prospective, single centered, triple blinded, randomized control trial was carried out from March 2009 till August 2010. 163 Head and Neck Cancer patients were screened of which 109 met the ideal inclusion and exclusion criteria. Blinding was done at three levels i.e. patients, assessor and data analysing statistician. The patients were block randomized into laser (54) and placebo (55) groups using a computer-generated program. Patients’ age and site of the primary tumour were matched in each block. All the patients completed the trial, 50 in each group.
Results: The oral mucositis scores were significantly lower in the patients receiving LLLT compared to the placebo group. There was a delay in development of mucositis in the laser group where all were treated with scanning laser. The incidence of grade III and IV mucositis was nearly 50% less in the study arm. At the end of 2nd week, 66% in the laser arm had no mucositis, in contrast to only 42% in the placebo arm. By the end of the 3rd week, 22% of the laser treatment patients were free of mucositis, while 8% were free of mucositis in placebo group. There is divergence of the two arms second week onwards, that is pronounced beyond the 5 weeks. The oral mucositis scores were consistently lower over the course of treatment in the laser arm, and the difference was statistically significant (p<0.001).
Conclusion: The Laser group showed a significant delay in the development of oral mucositis as compared to the Placebo group.