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

NCT03377270 | Completed Results DMC

• 1 other identifier: F2352-R
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer; Dysphagia

Keywords

Oropharyngeal Head and Neck Cancer; dysphagia; Respiratory Swallow Training

Outcome Measures

Primary Outcomes (1)

• Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score

  The MBSImP is a standardized outcome measure that evaluates swallowing physiology using 17 distinct component scores across the oral (components 1-6), pharyngeal (components 7-16), and esophageal (component 17) domains. Each component is rated on an ordinal scale based on specific physiologic impairments. Scores range from a minimum of 0 (no impairment) to a maximum of 2, 3, or 4, depending on the component. Higher scores indicate greater swallowing dysfunction, reflecting worse outcomes. For this analysis, the pharyngeal total (PT) score was used as a primary outcome measure. The PT score provides a comprehensive measure of overall pharyngeal function and is a sum of components 7 through 16. The PT Score ranges from 0 to 32, with higher scores indicating greater severity of impairment in pharyngeal swallowing function. A score of 0 represents no impairment, while a score of 32 represents the most severe impairment.

  Baseline, 30 days, 60 days, 120 days, 240 days

Secondary Outcomes (4)

• Maximum Penetration Aspiration Scale (PAS) Score

  Baseline, 30 days, 60 days, 120 days, 240 days

• MD Anderson Dysphagia Inventory (MDADI) Composite Score

  Baseline, 30 days, 60 days, 120 days, 240 days

• Functional Oral Intake Scale (FOIS) Score

  Baseline, 30 days, 60 days, 120 days, 240 days

• Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores

  Baseline, 30 days, 60 days, 120 days, 240 days

Study Arms (2)

Arm 1. Immediate Respiratory-Swallow Training

EXPERIMENTAL

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.

Behavioral: Respiratory Swallow Training

Arm 2. Delayed Respiratory-Swallow Training

OTHER

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.

Behavioral: Respiratory Swallow Training

Interventions

Respiratory Swallow Training BEHAVIORAL

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

Arm 1. Immediate Respiratory-Swallow Training; Arm 2. Delayed Respiratory-Swallow Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• months post head and neck cancer treatment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Edward Hines Jr. VA Hospital: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Bonnie Martin-Harris
• Organization: Northwestern University

bonnie.martinharris@northwestern.edu

847-467-0407

Study Officials

• Bonnie J. Martin-Harris, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor (those completed the swallow studies, those scoring)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized-controlled trial with 2 arms (intervention and control)

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)