Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer

NCT ID: NCT03377270

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-12-31

Brief Summary

Veterans following treatment of head and neck cancer can be left with lasting swallowing impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia. The investigators' previous trial tested a new swallowing treatment approach to target respiratory-swallow coordination. The results revealed improvements in respiratory-swallow coordination and swallowing function. The goal of this study is to determine the impact and durability of respiratory-swallow training (RST) on clinical outcomes necessary for eating, drinking, health, and quality-of-life in Veterans with swallowing impairment following treatment for head and neck cancer. A total of 50 participants will be recruited with a goal of 40 randomly assigned to immediate RST or delayed RST.

Detailed Description

Head and neck cancer (HNC) is a significant health issue in Veterans. In fact, Veterans have up to a two-fold increase in the incidence of HNC when compared to the general population. Further, they often suffer profound functional deficits associated with surgical ablation and toxicity from medical treatments used to cure or control local disease. Dysphagia (swallowing impairment) is common after such treatments, and has life-altering consequences [on health, quality-of-life, the ability to eat and drink normally, cost, and burden of care]. Despite important advancements in medical and surgical treatments that prolong survival, many Veterans with HNC, are faced with chronic, intractable dysphagia resulting in persistent drastic alterations in diet, the need for feeding tubes, and increased risk for aspiration pneumonia - a life threatening infection. The investigators must devote research and clinical efforts to mitigate these devastating impairments because the investigators' current rehabilitative intervention options are severely limited. As such, and in keeping with the VHA's Blueprint for Excellence Transformative Actions, the need for the development of effective swallowing interventions that show potential for rapid translation to clinical practice is imperative.

Coordination of respiration and swallowing is an essential element of airway protection during swallowing and facilitates many critical aspects of swallowing physiology. This key, coordinative event is significantly disrupted in patients with dysphagia following medical and surgical treatments for HNC. The investigators' previous trial in patients with severe and resistant dysphagia after cancer treatment and traditional swallowing therapy showed that targeting and recalibrating respiratory-swallow phase patterning directly through an innovative respiratory-swallow training (RST) method significantly improved aspects of swallowing physiology crucial for airway protection and clearance of ingested materials through the pharynx. These exciting new results led us to consider an expanded study with refined methods and a home practice (HP) component that will extend beyond physiologic efficacy and include more rigorous assessments of the clinical impact of RST. As with the investigators' preliminary trial, the investigators' prediction is that these innovative intervention methods will not only improve swallowing physiology and quality-of-life, but will also result in significant functional improvements in every day eating and drinking in Veterans with chronic, severe dysphagia that has been otherwise refractory to traditional swallowing intervention(s). The benefit of RST training is that it is a simple, straightforward method for patients to easily learn, and, when combined with the HP program, it is designed to facilitate patient compliance and maintenance of intervention effects. The investigators are also using commercially available and simple to use recording and analysis hardware and software that can easily be expanded to mobile technology for more widespread application to the many thousands of patients with dysphagia consequent to HNC.

A total of 50 participants will be recruited with the goal of 40 participants enrolled. Participants will be randomly assigned 1:1 to either immediate RST (intervention arm) or delayed RST (control arm). The participants in the control arm will have no active treatment for 4 weeks and will then participate in RST as a cross-over design. Data obtained will be used to evaluate clinical efficacy and durability The primary efficacy endpoint is physiologic function metrics of the oropharyngeal swallow, and the secondary endpoints are airway invasion and patient reported outcomes. We will use reproducible, reliable, and validated metrics that include the Modified Barium Swallow Impairment Profile and Penetration-Aspiration Scale to distinguish the mechanistic effects of RST.

The goal of this current study is to extend the investigator's preliminary trial that yielded compelling physiologic changes with potential to improve the impact and durability of RST on clinical outcomes essential for eating, drinking, health, and quality-of-life. The investigators' overarching goal is to provide two parallel tracks of knowledge generation: 1) provide immediate clinical translation of experimental findings to improve the lives of Veterans, and 2) drive model generation on fundamental mechanisms of motor coordination. Basic knowledge will drive clinical application and vice-a-versa. As such, this is an ideal experimental and clinical context that will fuel knowledge generation in this highly significant area of science and clinical practice.

Conditions

Head and Neck Cancer; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1. Immediate Respiratory-Swallow Training

Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.

Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).

Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.

Group Type: EXPERIMENTAL

Respiratory Swallow Training

Intervention Type: BEHAVIORAL

Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation

Arm 2. Delayed Respiratory-Swallow Training

Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.

Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).

Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.

Group Type: OTHER

Respiratory Swallow Training

Intervention Type: BEHAVIORAL

Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation

Interventions

Respiratory Swallow Training

Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Veteran and non Veterans
• have undergone treatment for a primary diagnosis of head and neck cancer (oral cavity, oropharyngeal, and hypopharyngeal)
• are 21 years of age
• 6 months post head and neck cancer treatment
• 6 months post-traditional swallowing treatment with continued dysphagia
• English speaking
• pass a cognitive screening (score 26 on the Montreal Cognitive Assessment (MoCA)
• do not present with severe chronic obstructive pulmonary disease (COPD) based on pulmonary function testing (PFT)
• drink less than 2 alcoholic beverages per day

Exclusion Criteria

• if they have known allergy or dietary restriction for contrast materials or liquids used during the MBSS or training
• currently drinking greater than two drinks per day
• severe COPD
• are unable to swallow one liquid consistency without the use of a compensatory strategy or swallow maneuver without aspiration
• history of aspiration pneumonia within the past 12 months

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward Hines Jr. VA Hospital

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonnie J. Martin-Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Northwestern University

Chicago, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

F2352-R

Identifier Type: -

Identifier Source: org_study_id