Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2017-07-12
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All subjects will be evaluated prior to initiation of cancer treatment (baseline assessment), 4 weeks into cancer treatment and again at the completion of cancer treatment (8 weeks after initiation of treatment). Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, and administration of swallow-related quality of life (QOL) questionnaires.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Researchers assessing the outcomes will not know the arm to which the subject was randomized.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active EMST + Standard Care
Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.
EMST
Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.
Sham EMST + Standard Care
Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.
EMST
Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EMST
Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Froedtert Hospital
OTHER
Medical College of Wisconsin
OTHER
University of Wisconsin, Milwaukee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barbara Pauloski
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barbara Pauloski
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Milwaukee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Stephanie Stevens, M.S.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephanie Stevens, MS
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO29168
Identifier Type: -
Identifier Source: org_study_id