医学
粘膜炎
安慰剂
相伴的
麻醉
不利影响
头颈部癌
临床终点
随机对照试验
外科
放射治疗
内科学
病理
替代医学
作者
Jordi Giralt,Yungan Tao,Rolf‐Dieter Kortmann,Xavier Zasadny,Jorge Contreras-Martínez,Philippe Céruse,F. Arias de la Vega,Rajesh V. Lalla,Esat Mahmut Özşahin,Gábor Pajkos,Andrew P. Mazar,P Attali,Paolo Bossi,B. Vasseur,Stephen T. Sonis,Michael Henke,René-Jean Bensadoun
标识
DOI:10.1016/j.ijrobp.2019.10.023
摘要
Oral mucositis (OM) is a frequent and painful sequela of concomitant chemoradiation (CRT) used for the treatment of head and neck cancer (HNC) for which there is no effective intervention. This randomized, placebo-controlled study evaluated the efficacy of a novel, mucoadhesive topical tablet formulation of clonidine in mitigating CRT-induced OM in patients with HNC.Patients with HNC undergoing adjuvant radiation therapy (60-66 Gy; 5 × 1.8-2.2 Gy/wk) with concomitant platinum-based chemotherapy received daily local clonidine at 50 μg (n = 56), 100 μg (n = 65), or placebo (n = 62) via a topical mucobuccal tablet starting 1 to 3 days before and continuing during treatment. The primary endpoint was the incidence of severe OM (severe OM [SOM], World Health Organization grade 3/4).SOM developed in 45% versus 60% (P = .06) of patients treated with clonidine compared with placebo and occurred for the first time at 60 Gy as opposed to 48 Gy (median; hazard ratio, 0.75 [95% confidence interval, 0.484-1.175], P = .21); median time to onset was 45 versus 36 days. Opioid analgesic use, mean patient-reported mouth and throat soreness, and CRT compliance were not significantly different between treatment arms. Adverse events were reported in 90.8% versus 98.4%, nausea in 49.6% versus 71.0%, dysphagia in 32.8% versus 48.4%, and reversible hypotension in 6.7% versus 1.6% of patients on clonidine versus placebo, respectively.Although the primary endpoint was not met, the positive trends of OM-associated outcomes suggest that the novel mucoadhesive tablet delivery of clonidine might favorably affect the course and severity of CRT-induced SOM and support further evaluation.
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