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.

项目摘要