Phase III trial of low-level laser therapy to prevent induced oral mucositis in head and neck cancer patients submitted to concurrent chemoradiation
| Autor: | L. F. Dias, Héliton Spíndola Antunes, I. A. Small, Elza Maria de Sá Ferreira, Carlos M.M. Araújo, Elida Cabral, Mariana P. Rampini, Tereza Giannini Pereira da Silva, Pedro Carvalho Rodrigues, Daniel Herchenhorn, Carlos Gil Ferreira, Nelson Teich |
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| Rok vydání: | 2011 |
| Předmět: |
Cisplatin
Cancer Research medicine.medical_specialty business.industry medicine.medical_treatment Head and neck cancer medicine.disease Placebo Dysphagia Gastroenterology Surgery law.invention stomatognathic diseases Oncology Randomized controlled trial Weight loss law Internal medicine otorhinolaryngologic diseases medicine Mucositis medicine.symptom business Low level laser therapy medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 29:LBA5524-LBA5524 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | LBA5524 Background: Oral mucositis (OM) remains a limiting factor in in head and neck squamous cell carcinomas (HNSCC) patients (pts) treated with chemoradiation (CRT) leading to pain, dysphagia, and weight loss. Low-level laser therapy (LLLT) emerges as a promising, preventive therapy of CRT-induced OM. Yet, a definitive randomized trial supporting its use is lacking. This study was designed to assess the efficacy of LLLT in reducing the incidence and/or severity of OM. Methods: Assuming OM grade (G3) for placebo 0.4 (P0); LLLT 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 LLLT and 47 placebo pts bearer of HNSCC of nasopharynx, oropharynx and hipopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional RT 70.2 Gy (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were OM incidence and severity, RT interruptions due to OM and pain intensity. The LLLT used daily was a diode InGaAlP (660nm-100mW-4J/cm²). OM evaluation was done by WHO and OMAS scale. Results: Mean age was 54.6 and 87.2% of pts were male. Primary site: oropharynx (74 pts), nasopharynx (9 pts), hypopharynx (11 pts). In the LLLT arm the incidence of OM G 3/4 was only 6.4% versus 48% in the placebo arm; HR of 0.13 (IC 95%, p |
| Databáze: | OpenAIRE |
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