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N/A N=49 Randomized Single-blind Treatment

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

Head and Neck Cancer · Dysphagia

Bottom Line

View on ClinicalTrials.gov: NCT03377270 ↗
Enrolled (actual)
49
Serious AEs
2.0%
Results posted
May 2025
Primary outcome: Primary: Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score — 11.00; 12.33; 9.84; 10.73 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Respiratory Swallow Training (Behavioral)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score		 11.00; 12.33; 9.84; 10.73; 10.17; 11.00 —
SECONDARY
Maximum Penetration Aspiration Scale (PAS) Score		 4.16; 4.73; 3.68; 3.60; 4.17; 3.92 —
SECONDARY
MD Anderson Dysphagia Inventory (MDADI) Composite Score		 63.33; 59.40; 64.17; 64.62; 66.63; 67.45 —
SECONDARY
Functional Oral Intake Scale (FOIS) Score		 5.56; 5.43; 5.56; 5.67; 5.64; 5.64 —
SECONDARY
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores		 59.60; 60.77; 60.50; 67.27; 60.00; 61.11 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03377270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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