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RECRUITINGINTERVENTIONAL

EMST in Patients Undergoing CRT for HNCA

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

Locations (2)

University of Wisconsin Milwaukee
Milwaukee, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States