Salivary Electrostimulation in the Treatment of Radiation Therapy–Induced Xerostomia (LEONIDAS-2): A Multicenter, Randomized, Double-Masked, Sham-Controlled, Phase 3 Trial

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
Valeria Mercadante,Arwa Al Hamad,James McCaul,Christopher M. Nutting,Kevin J. Harrington,Dawn Carnell,Teresa Guerrero Urbano,Nicholas Kalavrezos,Julie Barber,Stephen Porter,Stefano Fedele
出处
期刊:International Journal of Radiation Oncology Biology Physics [Elsevier]
卷期号:118 (1): 142-153 被引量:3
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. 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. 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). 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. LEONIDAS-2 did not meet the primary and secondary outcomes.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
腾腾完成签到 ,获得积分10
刚刚
kkkkk发布了新的文献求助10
1秒前
3秒前
wz完成签到,获得积分20
3秒前
gjww应助Victor采纳,获得10
6秒前
会飞的鱼发布了新的文献求助10
7秒前
8秒前
jiahao发布了新的文献求助10
9秒前
搜集达人应助玥来玥好采纳,获得10
9秒前
12秒前
谨慎外套完成签到 ,获得积分20
12秒前
用心听完成签到,获得积分20
12秒前
陈雷应助习樱采纳,获得10
14秒前
15秒前
15秒前
17秒前
Lucas应助zhang采纳,获得30
17秒前
17秒前
ID8发布了新的文献求助10
19秒前
21秒前
雷霆万钧完成签到,获得积分10
21秒前
22秒前
在水一方应助科研通管家采纳,获得10
22秒前
Ava应助科研通管家采纳,获得10
22秒前
wanci应助科研通管家采纳,获得10
22秒前
脑洞疼应助科研通管家采纳,获得10
22秒前
咕噜噜发布了新的文献求助10
23秒前
23秒前
Yziii应助科研通管家采纳,获得20
23秒前
Hello应助科研通管家采纳,获得10
23秒前
NexusExplorer应助科研通管家采纳,获得10
23秒前
酷波er应助科研通管家采纳,获得10
23秒前
23秒前
大模型应助科研通管家采纳,获得10
23秒前
Yziii应助科研通管家采纳,获得20
23秒前
科研通AI2S应助科研通管家采纳,获得10
23秒前
CodeCraft应助科研通管家采纳,获得10
24秒前
24秒前
华仔应助科研通管家采纳,获得10
24秒前
研友_VZG7GZ应助科研通管家采纳,获得10
24秒前
高分求助中
The ACS Guide to Scholarly Communication 2500
Sustainability in Tides Chemistry 2000
Pharmacogenomics: Applications to Patient Care, Third Edition 1000
Studien zur Ideengeschichte der Gesetzgebung 1000
TM 5-855-1(Fundamentals of protective design for conventional weapons) 1000
Genera Insectorum: Mantodea, Fam. Mantidæ, Subfam. Hymenopodinæ (Classic Reprint) 800
Ethnicities: Media, Health, and Coping 700
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3085834
求助须知:如何正确求助?哪些是违规求助? 2738698
关于积分的说明 7551384
捐赠科研通 2388489
什么是DOI,文献DOI怎么找? 1266613
科研通“疑难数据库(出版商)”最低求助积分说明 613512
版权声明 598591