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.
BACKGROUND
Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.


METHODS
Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm2. Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.


RESULTS
The 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.


CONCLUSIONS
While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.
Schubert
Mark M
MM
Department of Oral Medicine, Seattle Cancer Care Alliance, University of Washington, 825 Eastlake Ave E, Seattle, WA 98109, USA. mschuber@seattlecca.org
Eduardo
Fernanda P
FP
Guthrie
Katherine A
KA
Franquin
Jean-Claude
JC
Bensadoun
Rene-Jean J
RJ
Migliorati
Cesar A
CA
Lloid
C Michele E
CM
Eduardo
Carlos P
CP
Walter
Niccoli-Filho
NF
Marques
Marcia M
MM
Hamdi
Mohd
M
D000328:Adult; D000368:Aged; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D053685:Laser Therapy / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D011315:Preventive Medicine / Q000379:methods; D013280:Stomatitis / Q000517:prevention & control*; D016896:Treatment Outcome; D014861:Washington