唾液电刺激在放疗引起的口干症治疗中的应用（LEONIDAS-2）：一项多中心、随机、双盲安慰剂对照的第三阶段试验。
Salivary electrostimulation in the treatment of radiotherapy-induced xerostomia (LEONIDAS-2): a multicentre, randomised, double-masked sham-controlled phase 3 trial.
发表日期：2023 Mar 16
作者：
V Mercadante, A Al Hamad, J McCaul, C Nutting, K Harrington, D Carnell, T Guerrero Urbano, N Kalavrezos, J A Barber, S R Porter, S Fedele
来源：
Int J Radiat Oncol
摘要：
放射治疗所导致的口干症（RIX）显著影响头颈癌（HNC）幸存者的生活质量。腺体神经电刺激可以安全地增加自然唾液分泌，减轻口干症状。本研究采用多中心双盲随机安慰剂对照临床试验，评估商用口内腺体神经电刺激设备在减轻RIX症状、增加唾液流量和改善个体生活质量方面的长期影响。参与者通过计算机生成的随机化清单（1:1）分配到使用活性口内定制可拆卸电刺激设备或假装设备12个月。主要结果是在12个月内报告评估RIX视觉模拟评分（VAS）有30%改善的患者比例。另外还通过经过验证的测量（唾液量和VAS）和生活质量问卷（EORTC QLQ-H&N35、OH-QoL16和SF-36）评估了许多次要和探索性结果。按照方案，招募了86名参与者。意图分析显示，在主要结果和任何次要临床或生活质量结果方面，研究组之间没有统计学上的差异。探索性分析显示，在EORTC QLQ-H&N35的口干子量表得分的变化上，活性干预有显著的差异。LEONIDAS-2未达到主要和次要结果。NIHR研究的患者利益计划。版权所有©2023 Elsevier公司出版。
Radiotherapy-induced xerostomia (RIX) significantly affects quality of life in head and neck cancer (HNC) survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms.Multicentre double-masked randomised sham-controlled clinical trial to assess the long-term effects of a commercially available intra-oral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow and improving quality of life in individuals with RIX. Using a computer-generated randomization list, participants were assigned (1:1) to an active intra-oral custom-made removable electrostimulating device or a sham device to be used for 12 months. The primary outcome was the proportion of patients reporting a 30% improvement on the xerostomia VAS at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and VAS) and quality of life questionnaires (EORTC QLQ-H&N35, OH-QoL16 and SF-36).As per protocol, 86 participants were recruited. Intention-to-treat analyses showed no statistical evidence of a difference between the study groups with respect to the primary outcome or for any of the secondary clinical or quality of life outcomes. Exploratory analyses showed a statistically significant difference in the changes over time of the dry mouth sub-scale score of the EORTC QLQ-H&N35 in favour of the active intervention.LEONIDAS-2 did not meet the primary and secondary outcomes.NIHR Research for Patient Benefit Programme.Copyright © 2023. Published by Elsevier Inc.