Clinical trial · Interventional
Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer
Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in OP HNC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Respiratory Swallow Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1. Immediate Respiratory-Swallow Training
- description
- 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.
- interventionNames
- Behavioral: Respiratory Swallow Training
- type
- OTHER
- label
- Arm 2. Delayed Respiratory-Swallow Training
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available