Oral mucositis prevention by low-level laser therapy in head-and-neck cancer patients undergoing concurrent chemoradiotherapy: a phase III randomized study
Gouvêa de Lima A, Villar RC, de Castro G, Antequera R, Gil E, Rosalmeida MC, Federico MH, Snitcovsky IM
International journal of radiation oncology, biology, physics · 79 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- 2010-12-16 · Int J Radiat Oncol Biol Phys · vol. 82 · número 1 · págs. 270–275
- Editorial
- Elsevier BV
- Citado
- 127 citas · más que el 95% de estudios similares · 5.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Oral health in cancer treatment · Laser Applications in Dentistry and Medicine · Head and Neck Cancer Studies
- Palabras clave
- oral mucositis, low-level laser therapy, head and neck cancer, concurrent chemoradiotherapy, GaAlAs laser, cisplatin, oral cancer, mucositis prevention, radiation toxicity, pain scores, treatment efficacy comparison with placebo, dose escalation, head and neck squamous cell carcinoma
- MeSH
- humans, carcinoma, adenocarcinoma, clear cell, carcinoma, squamous cell, head and neck neoplasms, deglutition disorders, stomatitis, body weight, cisplatin, pain measurement, treatment failure, radiotherapy dosage, prospective studies, double-blind method, adult, aged, middle aged, brazil, female, male, lasers, semiconductor, young adult, chemoradiotherapy, low-level light therapy
8 autores
- Aline Gouvêa de Lima🇧🇷Universidade de São Paulo
- Rosângela Correa Villar🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Gilberto de Castro🇧🇷 · autor de correspondenciaInstituto do Câncer do Estado de São Paulo
- Reynaldo Antequera🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Erlon Gil🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Mauro Cabral de Rosalmeida🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Miriam Hatsue Honda Federico🇧🇷Universidade de São Paulo
- Igor Moisés Longo Snitcovsky🇧🇷Universidade de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
Oral mucositis is a major complication of concurrent chemoradiotherapy (CRT) in head-and-neck cancer patients. Low-level laser (LLL) therapy is a promising preventive therapy. We aimed to evaluate the efficacy of LLL therapy to decrease severe oral mucositis and its effect on RT interruptions.
Methods and materials
In the present randomized, double-blind, Phase III study, patients received either gallium-aluminum-arsenide LLL therapy 2.5 J/cm(2) or placebo laser, before each radiation fraction. Eligible patients had to have been diagnosed with squamous cell carcinoma or undifferentiated carcinoma of the oral cavity, pharynx, larynx, or metastases to the neck with an unknown primary site. They were treated with adjuvant or definitive CRT, consisting of conventional RT 60-70 Gy (range, 1.8-2.0 Gy/d, 5 times/wk) and concurrent cisplatin. The primary endpoints were the oral mucositis severity in Weeks 2, 4, and 6 and the number of RT interruptions because of mucositis. The secondary endpoints included patient-reported pain scores. To detect a decrease in the incidence of Grade 3 or 4 oral mucositis from 80% to 50%, we planned to enroll 74 patients.
Results
A total of 75 patients were included, and 37 patients received preventive LLL therapy. The mean delivered radiation dose was greater in the patients treated with LLL (69.4 vs. 67.9 Gy, p = .03). During CRT, the number of patients diagnosed with Grade 3 or 4 oral mucositis treated with LLL vs. placebo was 4 vs. 5 (Week 2, p = 1.0), 4 vs. 12 (Week 4, p = .08), and 8 vs. 9 (Week 6, p = 1.0), respectively. More of the patients treated with placebo had RT interruptions because of mucositis (6 vs. 0, p = .02). No difference was detected between the treatment arms in the incidence of severe pain.
Conclusions
LLL therapy was not effective in reducing severe oral mucositis, although a marginal benefit could not be excluded. It reduced RT interruptions in these head-and-neck cancer patients, which might translate into improved CRT efficacy.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.