医学
生活质量(医疗保健)
随机化
口干
随机对照试验
可视模拟标度
临床试验
放射治疗
头颈部癌
统计显著性
物理疗法
内科学
唾液
护理部
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
标识
DOI:10.1016/j.ijrobp.2023.03.047
摘要
Purpose
Radiation therapy–induced xerostomia significantly affects quality of life in head and neck cancer survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms. Methods and Materials
This multicenter, double-masked, randomized, sham-controlled clinical trial assessed the long-term effects of a commercially available intraoral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow, and improving quality of life in individuals with radiation therapy–induced xerostomia. Using a computer-generated randomization list, participants were assigned (1:1) to an active intraoral 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 visual analog scale at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and visual analog scale) and quality-of-life questionnaires (EORTC QLQ-H&N35, OH-QoL16, and SF-36). Results
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 subscale score of the EORTC QLQ-H&N35 in favor of the active intervention. Conclusions
LEONIDAS-2 did not meet the primary and secondary outcomes.
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