BACKGROUND The objective of the current study was to compare the safety and efficacy between 2 analgesic regimens for patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT). METHODS The current study was a prospective, single-institution, 2-arm, randomized pilot study. Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high-dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low-dose gabapentin (900 mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction. RESULTS A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; P = .002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01). CONCLUSIONS High-dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short-acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.

中文翻译：

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一项单机构、随机、试点研究，评估加巴喷丁和美沙酮对头颈部鳞状细胞癌放化疗患者的疗效。

背景 本研究的目的是比较两种镇痛方案对接受根治性放化疗 (CRT) 的头颈癌 (HNC) 患者的安全性和有效性。方法 本研究是一项前瞻性、单机构、2 组、随机试验研究。美国癌症联合委员会第七版 II 期至 IV 期头颈部鳞状细胞癌患者正在接受 CRT，被随机分配到第 1 组，其中需要高剂量加巴喷丁（每天 2700 毫克）和机构护理标准（氢可酮和/或对乙酰氨基酚根据需要进展为芬太尼），或第 2 组，其中包括低剂量加巴喷丁（每天 900 毫克）和美沙酮。主要终点是安全性和毒性。次要终点是疼痛、阿片类药物需求和生活质量 (QOL)。使用具有 Sidak 校正的广义线性混合回归模型比较治疗组在多个时间点的差异。结果 从 2015 年 4 月到 2017 年 8 月，共有 60 名患者（第 1 组 31 名和第 2 组 29 名）入组。在不良事件或严重不良事件方面，治疗组之间没有差异。治疗组之间的疼痛没有发现不同。第 1 组的更多患者在治疗期间不需要阿片类药物（42% 对 7%；P = .002）。第 2 组患者在多个领域的生活质量结果显着改善，包括整体健康 (P = .05)、身体机能 (P = .04)、角色功能 (P = .01) 和社会功能 (P = .01) . 结论：大剂量预防性加巴喷丁增加了治疗期间不需要阿片类药物的患者百分比。与短效阿片类药物和芬太尼方案相比，美沙酮可以改善生活质量。然而，无论治疗组如何，疼痛都会在整个治疗过程中显着恶化，因此需要进一步研究以确定更优化的治疗方案。