Department of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Road East, London, ON, N6A 5W9, Canada.
Departments of Clinical Neurological Sciences and Oncology, London Health Sciences Centre, 800 Commissioners Road East, London, ON, N6A 5W9, Canada.
BMC Palliat Care. 2021 Mar 19;20(1):45. doi: 10.1186/s12904-021-00735-0.
Radiation-induced mucositis (RIM) pain confers substantial morbidity for head and neck cancer (HNC) patients undergoing radiotherapy alone (RT) or chemoradiotherapy (CRT), often reducing treatment compliance. However, no standard currently exists for the treatment of RIM, and high dose opioid therapy, with its associated side effects and increased risk for chronic opioid use, remains the cornerstone of HNC pain management. The goal of this randomized clinical trial is to compare multimodal analgesia using analgesic medications with different mechanisms of action, to the institutional standard of opioid analgesia alone, in order to ascertain the optimal analgesic regimen for the management of RIM pain in HNC patients.
In this open-label, single-institution, non-inferiority, randomized clinical trial, sixty-two patients with mucosal head and neck malignancies treated with curative-intent radiation will be randomized in a 1:1 ratio, stratified by RT or CRT, between Arm 1: opioid analgesia alone as per the institutional standard, or Arm 2: multimodal analgesia using Pregabalin, Acetaminophen, and Naproxen, in addition to opioids, if required. The primary endpoint is the average 11-Numeric Rating Scale (11-NRS) score for pain during the last week of radiation treatment. Secondary endpoints include: average weekly opioid use, duration of opioid requirement, average daily 11-NRS score for pain, average weekly opioids dispensed, quality of life, hospitalizations for analgesic medication-induced complications, time to feeding tube insertion, weight loss, toxicity, treatment interruptions, and death within 3 months of completing RT treatment. Patients are eligible once analgesia is required for moderate 4/10 pain.
This study will assess the efficacy and safety of multimodal analgesia and its impact on opioid requirements, clinical outcomes, and quality of life, as a potential new standard treatment for RIM pain in HNC patients undergoing definitive RT or CRT.
ClinicalTrials.gov Identifier: NCT04221165 . Date of registration: January 9, 2020. Appendix 2 reports the World Health Organization trial registration dataset.
单纯放疗（RT）或放化疗（CRT）的头颈部癌症（HNC）患者发生放射性黏膜炎（RIM）疼痛会导致大量发病，常降低治疗顺应性。然而，目前尚无 RIM 的标准治疗方法，高剂量阿片类药物治疗及其相关副作用和增加慢性阿片类药物使用的风险仍然是 HNC 疼痛管理的基石。本随机临床试验的目的是比较使用不同作用机制的镇痛药物的多模式镇痛与单独使用阿片类药物的机构标准，以确定 HNC 患者 RIM 疼痛管理的最佳镇痛方案。
在这项开放标签、单机构、非劣效性、随机临床试验中，将 62 例接受根治性放疗的黏膜头颈部恶性肿瘤患者按 1:1 比例、按 RT 或 CRT 分层，随机分为 1 组：按机构标准单独使用阿片类药物镇痛，或 2 组：多模式镇痛，除阿片类药物外，还使用普瑞巴林、对乙酰氨基酚和萘普生。主要终点是放疗最后一周的平均 11 点数字评分量表（11-NRS）疼痛评分。次要终点包括：平均每周阿片类药物用量、阿片类药物需求持续时间、平均每日 11-NRS 疼痛评分、每周平均阿片类药物配给量、生活质量、因镇痛药物引起的并发症需要住院治疗、置管时间、体重减轻、毒性、治疗中断和完成 RT 治疗后 3 个月内死亡。一旦需要中度 4/10 疼痛的镇痛，患者即有资格入组。
本研究将评估多模式镇痛的疗效和安全性及其对阿片类药物需求、临床结局和生活质量的影响，作为接受确定性 RT 或 CRT 的 HNC 患者 RIM 疼痛的潜在新标准治疗方法。
ClinicalTrials.gov 标识符：NCT04221165。注册日期：2020 年 1 月 9 日。附录 2 报告了世界卫生组织试验注册数据集。
