Training Swallowing Initiation during Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

呼气期间开始吞咽训练：对口咽头颈癌治疗后安全性和效率的影响

• 批准号: 10469004
• 负责人: BONNIE J MARTIN-HARRIS
• 金额: $ 58.05万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10469004
• 关键词: Adverse effects; Aerodigestive Tract; Aftercare; Ambulatory Monitoring; Barium swallow; Biomechanics; Bolus Infusion; Breathing; Cancer Survivor; Clinical Trials; Complex; Controlled Clinical Trials; Custom; Deglutition; Deglutition Disorders; Eating; Environment; Epidemic; Fibrosis; Food; Frequencies; Goals; Head and Neck Cancer; Hour; Human Papillomavirus; Impairment; Individual; Ingestion; Intervention; Larynx; Lead; Life; Limb structure; Liquid substance; Measures; Mission; Monitor; Movement; National Cancer Institute; Operative Surgical Procedures; Oropharyngeal; Outcome; Participant; Patients; Pattern; Penetration; Pharyngeal structure; Phase; Physiological; Physiology; Positioning Attribute; Posture; Radiation; Randomized; Recovery; Research Institute; Respiration; Safety; Severities; Sexually Transmitted Diseases; Signal Transduction; Survival Rate; Survivors; Testing; Therapeutic; Time; Tissues; Tongue; Toxic effect; Traction; Training; United States; Wakefulness; Work; arm; cancer therapy; chemotherapy; clinical translation; curative treatments; drinking; expiration; functional gain; improved; injured airway; innovation; novel; novel therapeutics; primary endpoint; recruit; remote therapy; respiratory; response; secondary endpoint; sensor; smartphone Application; telehealth; traditional therapy; visual feedback; vocal cord; wearable sensor technology

PROJECT SUMMARY ABSTRACT Oropharyngeal head and neck cancers (OP HNC) have increased to epidemic levels in the United States.1,2 Despite good response to cancer treatment,3 survivors are suffering life-long toxicities that result in swallowing problems (dysphagia).4,5 Treatment options for dysphagia after OP HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning.6-11 Prior evidence has demonstrated that of impairments, when aberrant respiratory-swallow phase patterning is present ( initiation swallowing during nspiration ) in patients with OP HNC, there is a higher occurrence of swallowing increased residue, and airway invasion. 12,13 i Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing.14-17 Thus, we developed and tested an innovative approach to train individuals with dysphagia after OP HNC to initiate swallowing during expiration.18 In this preliminary trial, we found that training initiation of swallowing during expiration resulted in marked improvements in airway protection and key physiologic components of swallowing function.18 These compelling findings led us to the current randomized, Phase II, sham-controlled clinical trial to test if this respiratory-swallow phase training approach will improve airway protection and swallowing efficiency in OP HNC survivors in the subacute phase (3-6 mo.) of recovery. Our primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. Our secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. We will recruit 88 OP HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. They will be randomized 1:1 into Experimental (n=44) or Sham (n=44) group arms. We will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory- swallow movements. Primary endpoints for Aim 1: frequency (%) of swallows initiated during expiration and Penetration-Aspiration Scale19 scores. Secondary endpoints: Normalized Residue Ratio Scale20 and Modified Barium Swallow Impairment Profile21,22 scores. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment. The primary endpoint for Aim 2 is frequency (%) of swallows initiated during expiration in wakeful, natural contexts measured at baseline, during training, within 1-week post-treatment, and 2-, 4-, 6-, 8-, 10-, and 12-weeks post-treatment. Consistent with the NCI's mission, this proposed study investigates a new therapy option that could be combined with traditional therapies to improve swallowing recovery for survivors of OP HNC.

项目概要摘要 在美国，口咽头颈癌 (OP HNC) 已达到流行水平。1,2 尽管对癌症治疗反应良好，3 幸存者仍遭受导致吞咽的终生毒性 问题（吞咽困难）。4,5 OP HNC 后吞咽困难的治疗选择极其有限，重点关注 仅吞咽动作，不考虑呼吸-吞咽阶段模式的重要性。6-11 先前的证据表明 的 损伤， 当存在异常的呼吸-吞咽阶段模式时（启动 吸气期间吞咽）OP HNC 患者吞咽发生率较高 残留增加和气道侵入。 12,13 我 此外，已经明确的是，呼气 呼吸周期的肢体提供了生物力学上有利的设定点，在该设定点中开始安全和 高效吞咽。14-17 因此，我们开发并测试了一种创新方法来训练个体 OP HNC 在呼气期间开始吞咽后出现吞咽困难。18 在这项初步试验中，我们发现训练 呼气时开始吞咽可显着改善气道保护和关键功能 吞咽功能的生理组成部分。18 这些令人信服的发现使我们得出了当前的随机、 II 期假对照临床试验，测试这种呼吸吞咽阶段训练方法是否会有所改善 OP HNC 幸存者在亚急性恢复期（3-6 个月）的气道保护和吞咽效率。 我们的主要目标（目标 1）是确定呼吸吞咽阶段训练是否会导致频率增加 (%) 呼气期间开始吞咽并提高吞咽安全性。我们的次要目标（目标 2）是检查 呼吸-吞咽阶段训练对呼气期间开始吞咽频率的影响 清醒、自然的吞咽环境，包括饮食。我们将招募 88 名 OP HNC 幸存者 伴有吞咽困难、呼吸-吞咽阶段模式受损和气道受损。他们将是 按 1:1 随机分为实验组 (n=44) 或假手术组 (n=44)。我们将使用远程提供治疗 远程医疗平台和创新的可穿戴传感器，可提供呼吸系统的实时视觉反馈 吞咽动作。目标 1 的主要终点：呼气期间开始吞咽的频率 (%) 渗透-渴望量表19 分。次要终点：标准化残留率 Scale20 和改良版 吞钡损伤概况21,22 分。端点将通过同步视频荧光镜测量 基线、治疗后 1 周内以及 1 个月和 3 个月内的呼吸吞咽传感器记录 治疗后。目标 2 的主要终点是清醒时呼气期间开始吞咽的频率 (%)， 在基线、训练期间、治疗后 1 周内以及 2、4、6、8、10 和 治疗后12周。与 NCI 的使命一致，这项拟议的研究调查了一种新疗法 该选项可以与传统疗法相结合，以改善 OP HNC 幸存者的吞咽恢复。