Impact of breathing exercises on swallowing in head and neck cancer patients
Official title: Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy (CRT) for Cancers of the Head and Neck (HNCA)
Run by University of Wisconsin, Milwaukee · NCT03916809 · Data updated 2026-11-12
This study is testing if breathing exercises can help improve swallowing for people with newly diagnosed head and neck cancer who are getting radiation or chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Wisconsin, Milwaukee Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Milwaukee, Wisconsin and 1 other locations) |
| Status | Recruiting |
| Started | July 12, 2017 |
| Main results expected | August 1, 2025 |
| Study ends | August 1, 2025 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT03916809 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older with a new diagnosis of oral cavity, oropharynx, hypopharynx, or larynx cancer scheduled for radiation therapy.
✕Probably not a fit
Patients with prior head and neck surgery or those with progressive neurological conditions affecting muscle strength may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effects of expiratory muscle strength training (EMST) on swallowing function in patients with newly diagnosed head and neck cancer undergoing radiation therapy or chemoradiotherapy. Participants will be randomly assigned to either an active EMST program combined with standard care or a sham EMST program with standard care over an 8-week period. The study will assess swallowing function through maximum expiratory pressure measurements, videofluoroscopic swallow studies, and quality of life questionnaires at baseline, 4 weeks, and 8 weeks after treatment initiation.
Why it matters
Potential benefit: If successful, this approach could enhance swallowing safety and efficiency in patients undergoing treatment for head and neck cancer.
How similar studies have gone: Other studies have shown promising results with similar interventions, suggesting potential efficacy in improving swallowing function.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx; * Planned treatment with primary radiotherapy with or without chemotherapy; * Age 18 or older and able to provide consent; * Ability to use the EMST150 device (hold in mouth and maintain lip seal) Exclusion Criteria: * Primary surgery to the head and neck (neck dissection is permitted); * Unknown primary tumor; * Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin. * Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease) * Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI)) * Prior history of head and neck radiotherapy
Where it's running
-
Froedtert Hospital
Milwaukee, Wisconsin, United States Recruiting -
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States Active not recruiting
Study contacts
- Principal investigator: Barbara Pauloski — University of Wisconsin, Milwaukee
- Study coordinator: Barbara Pauloski, Ph.D.
- Email: pauloski@uwm.edu
- Phone: 4142296719
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.