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
Schubert MM, Eduardo FP, Guthrie KA, Franquin JC, Bensadoun RJ, Migliorati CA, Lloid CM, Eduardo CP, Walter NF, Marques MM, Hamdi M
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 148 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2007-03-29 · Support Care Cancer · vol. 15 · número 10 · págs. 1145–1154
- Editorial
- Springer Science+Business Media
- Citado
- 251 citas · más que el 99% de estudios similares · 13.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 35 trabajos
- Acceso
- De pago
- Áreas de investigación
- Oral health in cancer treatment · Laser Applications in Dentistry and Medicine · Oral Health Pathology and Treatment
- Palabras clave
- low-level laser therapy, oral mucositis, hematopoietic stem cell transplantation, mucositis prevention, GaAlAs laser, 650 nm wavelength, oral pain, conditioning chemotherapy, chemoradiotherapy, oral mucosa
- MeSH
- humans, stomatitis, treatment outcome, hematopoietic stem cell transplantation, preventive medicine, adult, aged, middle aged, washington, female, male, laser therapy
11 autores
- Mark M. Schubert🇺🇸 · autor de correspondenciaSeattle Cancer Care Alliance; University of Washington; Fred Hutch Cancer Center
- Fernanda de Paula Eduardo🇧🇷Universidade de São Paulo
- Katherine Adams Guthrie🇺🇸Fred Hutch Cancer Center
- Jean Claude Franquin🇫🇷Aix-Marseille Université
- René‐Jean Bensadoun🇫🇷Centre Antoine Lacassagne
- Cesar Augusto Migliorati🇺🇸Nova Southeastern University
- C. Michele E. Lloid🇺🇸Seattle Cancer Care Alliance
- Carlos Eduardo🇧🇷Universidade de São Paulo
- Walter Niccoli‐Filho🇧🇷Universidade Estadual Paulista (Unesp)
- Márcia Martins Marques🇧🇷Universidade de São Paulo
- Mohd Hamdi
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
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.
Materials and 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.
Discussion
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.
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