Genot-Klastersky, M.T., Klastersky, J., Awada, F., Awada, A., Crombez, P., Martinez, M.D., et al. (2008). The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: Results from two prospective studies. Supportive Care and Cancer, 16(12), 1381–1387.

100 mW laser was delivered to tissues with a 1.2 mm spot size. Treatment areas included inferior and superior lips, right and left cheeks, right and left tongue, palate and velum palate, right and left gums, and tongue frenulum.

Average energy was 2 J/cm² on all sites, with a calculated mean duration of 33 seconds per site; each treatment lasted six minutes.

1. Three sessions per week
2. Started within 24 hours of diagnosis and given every other work day

(1) Patients with various solid tumors treated with chemotherapy; previous oral mucositis of 2 or higher

26 patients for 90% power

Patients with concomitant RT and those \"expected to be poor compliers to the treatment schedule\" were excluded.

Mean age 51 was years (range = 32–73 years).
20 women; 6 men

(2) Randomized trial for patients with hematologic malignancies who developed mucositis receiving radiochemotherapy prior to HSCT. Therapy started 24 hours after diagnosis of mucositis. Sham laser control was used.
20 patients were needed in each arm for 90% power.

n = 36 (18 patients in each arm)
 

Grade of mucositis using EORTC scale

Grading was performed by a nurse prior to each treatment session and afterward once a week by an independent blinded professional observer.

All treated areas were examined.
 

1. 21 of 26 patients were considered to have prevented mucositis (81%, 95% CI = 61%–93%); 4 with no mucositis, and 17 with grade I. Five patients had grade 2 or higher; median duration was 10 days (range = 8–14 days).

2. Grade 3 mucositis was observed in 16 patients in the sham group and in 3 LEL treated patients (p = 0.001). Overall success rate was 15 of 18 (83%, 95% CI = 59%–96%) and 2 of 18 in the control group (11%, 95% CI = 1–35).Time to grade 3 mucositis was calculated (p < 0.0001).

Of 16 patients in the control arm who developed grade 3–4, eight later received laser treatment; regression to grade 1 mucositis was three days in this group and four days in those who did not receive LEL.
 

Limited sample size, although the prevention trial (1) achieved 90% power.

The heterogeneous population in the prevention trial makes the results difficult to generalize. Oral care and other factors were not reported.