Schubert, M.M., Eduardo, F.P., Guthrie, K.A., Franquin, J., Bensadoun, R.J., Migliorati, C.A., et al. (2007). A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Supportive Care in Cancer, 15(10), 1145–1154.

Low level laser therapy (LLLT) using two different low level GaAIAs diode lasers was administered 650 nm to group I and 780 nm to group II compared to sham treatment in the placebo group (group III) beginning on the first day of conditioning and continuing through two days after HCT.

Assessors and patients were blinded; only the laser therapist knew the treatment type.

Powered for 22 subjects per group

70 patients were treated on protocol.

Group 1: n = 23
Group 2: n = 24
Group 3: n = 24


The median age was 44–48 years (range = 18–69 years).

Autologous versus allogeneic was 17% versus 82% in group I, 9% versus 90% in group 2, and 8% versus 92% in group III.
 

February-November 2001

Randomized, double-blind, placebo-controlled study of patients with HCT

Oral mucositis index OMI and VAS for pain

0, 4, 7, 11, 14, 18, 21
 

State mean OMI scores varied most at day 11. Scores approached significance (p = 0.06 not significant) when adjusted. Patient-specific average OMI scores for TBI were p = 0.03 (group I) and p = 0.23 (group II).

Two patients died with severe mucositis.
 

Patients in the placebo group appeared to have suffered more pain than patients in the laser treatment group, particularly group I.

The study demonstrated a tendency for LLLT to reduce severity of mucositis during the second week.

Pain data were incomplete; some patients were too ill to do VAS.

Although randomly assigned, TBI and busulfan/cytoxan were not equally distributed.

Small sample size

Set up as a prevention trial, so treatment only occurred through day 2.