NCT03916809 EMST in Patients Undergoing CRT for HNCA
| NCT ID | NCT03916809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Milwaukee |
| Condition | Head and Neck Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-07-12 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2017-07-12 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).
Eligibility 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
Contact & Investigator
Barbara Pauloski
PRINCIPAL INVESTIGATOR
University of Wisconsin, Milwaukee
Frequently Asked Questions
Who can join the NCT03916809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03916809 currently recruiting?
Yes, NCT03916809 is actively recruiting participants. Contact the research team at pauloski@uwm.edu for enrollment information.
Where is the NCT03916809 trial being conducted?
This trial is being conducted at Milwaukee, United States, Milwaukee, United States.
Who is sponsoring the NCT03916809 clinical trial?
NCT03916809 is sponsored by University of Wisconsin, Milwaukee. The principal investigator is Barbara Pauloski at University of Wisconsin, Milwaukee. The trial plans to enroll 30 participants.