Oral mucositis prevention by low-level laser therapy in head and neck cancer patients submitted to concurrent chemoradiation: A prospective randomized study

Autor: Miriam Hatsue Honda Federico, M. C. Rosalmeida, M. V. Ortegosa, R. C. Villar, A. I. Cavalcanti Leal, I. M. L. Snitcovsky, A. G. de Lima, Erlon Gil, Gilberto de Castro, Dcos Lopes
Rok vydání: 2009
Předmět:
Zdroj: Journal of Clinical Oncology. 27:6019-6019
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2009.27.15_suppl.6019
Popis: 6019 Background: Oral mucositis is a major treatment-related complication of concurrent chemoradiation (CRT) in head and neck cancer (HNC) patients (pts), affecting nutrition, pain control, quality of life and adequate treatment delivery. Low level laser (LLL) is a promising preventive therapy. We aimed to evaluate the efficacy of LLL to decrease and delay severe oral mucositis and its impact on RT interruptions. Methods: In this prospective, randomized, double-blind, phase III trial, pts were treated with either daily He-Ne LLL 2.5 J/cm2, or placebo laser, before RT. Eligible pts had to be diagnosed with SCC or undifferentiated carcinoma of oral cavity, pharynx, larynx, or metastatic to the neck with unknown primary site (UPS); age > 18 y; candidates to adjuvant or definitive CRT; signed informed consent. CRT consisted of conventional RT 60–70 Gy (1.8–2.0 Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were oral mucositis severity in wks 2, 4 and 6 (CTC-NCI v.2.0); RT interruptions due to mucositis; pain intensity (VAS). To detect a decrease in the incidence of grade 3 or 4 oral mucositis from 80 to 50%, we planned to enroll 74 pts, error I/II 5 and 20%, respectively. Results: 73 pts were included (77% male; mean age 53 y); primary site: oropharynx (31 pts), larynx (15), nasopharynx (10), hypopharynx (8), oral cavity (7 pts), UPS (2); 36 pts received prophylactic LLL. Mean delivered RT dose (Gy) was higher in pts treated with LLL (69.3 vs. 67.8, p = 0.04). The number of treatment fields was the same (6 vs. 6, p = 0.50) and the mean cisplatin dose-intensity was 40.9 and 40.1 mg/m2/wk (p = 0.3) between pts treated with LLL or placebo, respectively. During CRT, the number of pts diagnosed with grade 3 or 4 oral mucositis treated with LLL/placebo was 4/5 (wk 2, p = 1.0); 4/11 (wk 4, p = 0.08); and 8/9 (wk 6, p = 1.0), respectively. More pts treated with placebo had RT interruptions due to mucositis (6 vs. 0, p =0.02). The occurrence of severe pain did not differ between the study arms in wks 2, 4 and 6 (5/5, 8/8 and 8/8, p = 1.0). Conclusions: LLL therapy was effective in reducing grade 3 or 4 oral mucositis and in reducing RT interruptions in these HNC pts treated with concurrent CRT, which may translate into improved CRT efficacy and tolerance. No significant financial relationships to disclose.
Databáze: OpenAIRE
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