A randomized controlled trial of visible-light therapy for the prevention of oral mucositis.

The objective of this study was to assess the efficacy of a novel visible-light therapy (VLT) device for the prevention of oral mucositis in hematopoietic stem cell transplantation (HSCT) patients. A VLT-device suitable for intra-oral use was applied to 20 patients undergoing HSCT. The study design was placebo-controlled, randomized and double-blind. Oral mucositis was assessed using the OMAS and WHO scales. Oral pain and acceptance levels were scored by the patient using a 10-step scale. Patients were evaluated once a week until day 21 post-HSCT. Mucositis rate, severity and pain score were compared. At the third visit, 1week post-HSCT, mucositis rates were significantly lower in the treatment group (for both WHO and OMAS p=0.02). Mucositis was also less severe in the treatment group (for WHO p=0.01; for OMAS p=0.01). Furthermore, the patients in the treatment group reported lower pain levels (p=0.04). The treatment was well tolerated and highly accepted, with no reports of adverse events related to the device. These findings suggest that the VLT-device is safe and effective for the prevention of oral mucositis in patients undergoing HSCT.