NCT03377270Completed
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 · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 8 Dec 2017
- Start date
- 1 Oct 2018
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Head and neck cancer
- NCT number
- NCT03377270
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From 1 Oct 2018 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- if they have known allergy or dietary restriction for contrast materials or liquids used during the MBSS or training
- history of aspiration pneumonia within the past 12 months
Other
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Edward Hines Jr. VA Hospital, Hines, IL Coordinator of this site? Confirm its status | Hines | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.