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: 10280438
• 负责人: BONNIE J MARTIN-HARRIS
• 金额: $ 58.64万
• 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/10280438
• 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.

项目摘要摘要 在美国，口咽头和颈部癌（OP HNC）已增加到流行水平。1,2 尽管对癌症治疗的反应良好，但3个幸存者仍患有终身毒性，导致吞咽 问题（吞咽困难）.4,5 OP HNC后吞咽困难的治疗选择极为有限，专注于 单独吞咽动作，并且不考虑呼吸道绞合阶段图案的重要性。6-11 先前的证据表明 的 障碍， 当存在异常的呼吸戒烟相位构图时（启动 在Nspiration期间吞咽）在患有HNC的患者中，吞咽的发生较高 残留物增加和气道入侵。 12,13 我 此外，已经确定了呼气 呼吸周期的肢体提供了一个在生物力学上有利的设定点，在其中启动安全和 14-17因此，我们开发并测试了一种创新方法，以培训 OP HNC之后的吞咽困难在到期期间吞咽。18在此初步试验中，我们发现培训 到期期间吞咽的启动导致气道保护和钥匙有明显改善 吞咽功能的生理成分。18这些引人入胜的发现使我们达到了当前的随机， 第二阶段，假对照的临床试验，以测试这种呼吸剂量含量的相训练方法是否会改善 在恢复的亚急性期（3-6个月）中，OP HNC幸存者的气道保护和吞咽效率。 我们的主要目标（AIM 1）是确定呼吸道戒烟相位训练是否导致频率增加（％） 在到期期间发起的燕子和改善的吞咽安全性。我们的次要目标（AIM 2）是检查 呼吸道绞合期相训练对在到期期间发起的燕子频率的影响 清醒，自然主义的吞咽环境，包括饮食。我们将招募88个OP HNC幸存者 吞咽困难，呼吸丝丝式相位图案受损和气道妥协。他们会的 随机分为实验（n = 44）或假（n = 44）组臂。我们将使用 远程医疗平台和创新的可穿戴传感器，可提供呼吸道的实时视觉反馈 - 吞咽动作。 AIM 1的主要终点：到期期间发起的燕子的频率（％）和 渗透吸气量表19分。次要终点：归一化的残基比量表20并修改 钡吞咽损伤概况21,22。终点将从同步视频荧光镜测量 在基线时，治疗后1周内以及1个月和3个月的呼吸道焊接传感器记录 治疗后。 AIM 2的主要终点是在唤醒期到期期间发起的燕子的频率（％）， 在基线，训练期间，在1周内进行治疗和2-，4-，4-，6-，8-，10-和 研究后12周。这项拟议的研究与NCI的任务一致，研究了一种新的疗法 可以与传统疗法相结合的选择，以改善Op HNC幸存者的吞咽恢复。