Light Therapy/Visible Light Therapy

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.

A prospective study to compare the effect of an established laser therapy protocol with a potential therapy utilizing LED (light-emitting diode) on chemotherapy-induced oral mucositis

1. Physical examination was done on all patients and oral hygiene instructions were given to patients at the start of treatment.
2. Oral examinations were conducted during irradiation sessions and the degree of mucositis and pain were recorded daily.
3. Two different phototherapeutic protocols were used randomly from the time of the patient’s registration to 12–15 days later.
4. Patients received 10 consecutive days of irradiation, except for weekends.
5. Patients in group 1 received one laser phototherapy protocol of InGaAIP diode laser with a wavelength of 660 nm. Irradiation time was six seconds per point based on the laser beam spot size of 0.036 cm². Irradiations were performed intraorally: 12 points on each buccal mucosa, 8 on the superior and inferior labial mucosa, 12 on the hard palate, 4 on the soft palate, 12 on the lingual dorsum, 6 on the lateral edge of the tongue bilaterally, 2 on the right and left pillar of the tongue, 4 on the floor of the mouth, and 1 on the labial commissure bilaterally.
6. Patients in group 2 received one LED phototherapy protocol. The dentists were trained to perform LED irradiation in a standardized manner.
7. Irradiations were performed daily for 10 consecutive days, except for weekends, with a wavelength of 630 nm and with the same energy per point as was used in in laser protocol. Laser power was 40 mW, energy density of 6.6J/cm², power density of 1.1W/cm², and energy per point of 0.24J. Irridation was punctual, in contact, and perpendicular to the oral mucosa. Irradiations were performed intraorally in the same manner as for group 1.
8. For both radiation protocols before and after each session, power output was checked using a power meter.
9. Patient self-assessed pain was measured using a visual analog scale (VAS) for pain from 0 to 10 and was done prior to each laser/LED session.

• N = 4
• AGE RANGE: Group 1: 50.5 (+/– 14.7) years, Group 2: 57.4 (+/– 11.3) years 
• MALES: Group 1: 10 (44%), Group 2: 5 (29%) 
• FEMALES: Group 1: 13 (56%), Group 2: 12 (71%) 
• KEY DISEASE CHARACTERISTICS: Patients with chemotherapy-induced oral mucositis grades I, II, or III. Breast cancer was the most common cancer in both groups. A wide variety of chemotherapy were treatments used.

• LOCATION: Sao Paulo, Brazil

• PHASE OF CARE: Treatment
• APPLICATIONS: Patients with chemotherapy-induced oral mucositis grades I, II, and III

• Prospective trial

• World Health Organization (WHO) criteria for oral mucositis
• Visual analog scale (VAS) for pain (0 to 10)

• Beginning grade of mucositis did not differ between groups (p < 0.05).
• In the LED group, within-group analysis showed a significant decrease in mucositis from day 1 to days 7, 8, 9, and 10 (p < 0.05).
• In the laser group, within-group analysis showed a significant decrease in mucositis from day 1 compared to day 10 (p < 0.05).
• A trend was seen for both treatment groups. The higher the initial mucositis score, the more treatment that was required to improve mucositis. The trend was not statistically significant.
• Comparing the mucositis scores between the laser and LED groups according to patients initial mucositis grade, only in those patients with the initial mucositis score III (p = 0.028) was the LED treatment more effective in healing oral lesions than the laser treatment.
• Comparing the mean of VAS scores for laser and LED, according to the patients' initial mucositis scores, the LED treatment was more effective for patients with initial the mucositis scores I and II (p = 0.012 and p = 0.022).

Both therapies analyzed in this study were efficient in preventing breaks in treatment.

• The groups were not evenly matched for men and women.
• Risk of bias (no control group)
• Unsure how the randomization process was achieved; not stated in report
• Dentists were taught how to do WHO mucositis assessments, but the article did not speak to the training received.
• The LED power was twice as strong as the laser power, resulting in three and six seconds of irradiation per point, respectively. One advantage of the LED phototherapy protocol over the Laser protocol is that much less time is required to irradiate through the oral cavity.

LED phototherapy may be a viable alternative to traditional laser therapy to treat oral mucositis. This study, however, is small and has several flaws. Nurses should educate patients on proper oral hygiene to be used in combination with LED and laser therapy to promote optimal healing.