Photobiomodulation Therapy in the Prevention of Chemotherapy Induced Oral Mucositis in Children with Acute Myeloid Leukemia: A Randomized, Double-blind, Clinical trial.

Abstract

Background: Many preventive modalities have been advocated to reduce the incidence and severity of chemotherapy-induced Oral Mucositis (OM). Photobiomodulation, also known as Low-Level laser. Therapy, has shown promising results. This clinical trial was performed to evaluate the effectiveness of Photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in children with Acute Myeloid Leukemia (AML).

Patients and methods: A double-blinded randomized clinical trial was performed, including forty-two children diagnosed with Acute Myeloid Leukemia (AML) admitted to receiving chemotherapy (CT) at Children's Cancer Hospital 57357, Cairo, Egypt. Patients were randomly assigned to either the control or test group. Both groups followed the standard preventive protocol for oral mucositis. In the control group I sham therapy, while in the Laser group I had Photobiomodulation sessions for five consecutive days once a day performed by Diode laser (Sirrolaser Blue ™, USA) 660nm, 15watt, 10 s. Laser sessions began on day 1 of chemotherapy and were repeated on days 2,3, 4, and 5. The response to both groups was evaluated according to the development of oral mucositis; graded using the classification criteria of the World Health Organization (WHO) and the National Cancer Institute scale (NCI - Common Terminology Criteria for Adverse Events, version 4.0). Incidence of oral mucositis was evaluated from baseline to 5, 12, 19, and 30 days after treatment.

Results: A clinical significant difference between the laser and control group was observed. The laser group showed a higher prevalence of no oral mucositis with decreased incidence of OM, while on day 12, the control group showed a higher prevalence of grades I and II (P-value <0.001, effect size = 0.796). However, the laser group showed higher prevalence of mucosa free of OM; on day 19, the control group showed higher rates of grades II and III, (P-value <0.001, effect size = 0.670). while on day 30 there was higher rates of grades I and II (P-value <0.001, effect size = 0.576) with higher rates of healthy oral mucosa in the laser group.

Conclusion: Photobiomodulation effectively reduces the incidence and severity of chemotherapy-induced oral mucositis in pediatric patients diagnosed with AML.