Elad, S., Luboshitz-Shon, N., Cohen, T., Wainchwaig, E., Shapira, M. Y., Resnick, I. B., et al. (2011). A randomized controlled trial of visible-light therapy for the prevention of oral mucositis. Oral Oncology, 47(2), 125-130.

To assess the efficacy of a visible-light therapy device for the prevention of OM in HSCT patients.

All patients received preventive protocols that included prophylactic antivirals for those at risk for infection, cyclosporine as GVHD prophylaxis in allogeneic transplant patients, and standard topical antibacterial and antifungal prophylaxis with chlorhexidine, Nystatin, and saline rinses. Subjects were randomized to the study group (N = 10) who received broad band visible light (BBVLT) therapy starting on the first day of conditioning 5 times per week, continuing until at least day 21 if score was 0 on OMAS and WHO Scales. Subjects assigned to the placebo group received sham therapy using a similar device. Otherwise treatment was continued until day 28. Patients were evaluated daily, and oral mucosa was evaluated weekly by the research team.

The study was comprised of 19 patients, age 24.5 - 66 years.

Males (%): 53, Females (%): 47

Key Disease Characteristics: Leukemia, lymphoma, five patients listed as other (2 active Rx, 3 Placebo).

Other Key Sample Characteristics: Adult patients receiving myeloablative and non-myeloablative conditioning regimens with chemo + or - TBI and prophylaxis. Examined prior to treatment to confirm intact mucosal lining. Karnofsky score greater than 60.

Site: Single site

Setting Type: Not specified

Location: Hadassah University Medical Center - Department of Bone Marrow Transplantation

Phase of Care: Active treatment

Randomized, placebo controlled and double blinded

• WHO Mucositis Scale    
• Oral Mucositis Assessment Scale
• BB-VLT device
• Clinical exam daily by the attending physician. Weekly oral mucosa monitoring by the research team.
• Pain was scaled weekly using a VAS 0 - 10 analog scale.
• Satisfaction with treatment modality were evaluated on 0-10 scale.
   

There was a statistically significant difference in both the frequency of patients with no mucositis and the severity of the mucositis based on the WHO and OMAS scales at visit three only (p = 0.02) . Other than that, there were no statistically significant differences in frequency or severity of mucositis between the two groups.  There was no significant difference in narcotic consumption between the two groups. Satisfaction was highly rated in both groups.

There were significantly better mucositis scores and lower pain levels in the treatment group at one week post-HSCT. Treatment was well tolerated with no adverse events related to the study device. The conclusion is that the BB-VLT device is safe and effective in the prevention of oral mucositis in HCST patients.

Small sample <30

Costly treatment, though less so than lasers. Significant differences were seen at only one time point.

Needs further study, though device appears easy to use and safe. BBVLT therapy may be a less costly alternative to laser treatments, and the device used could be operated by patients themselves for self care. Larger studies in this area are warranted.