EMST in Patients Undergoing CRT for HNCA
Head and Neck Neoplasms, Deglutition Disorders
About this trial
This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training
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
Sites / Locations
- University of Wisconsin Milwaukee
- Froedtert HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active EMST + Standard Care
Sham 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.
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.