EMST in Patients Undergoing CRT for HNCA
Purpose
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).
Conditions
- Head and Neck Neoplasms
- Deglutition Disorders
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function.
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Subjects will not know whether the device that they are given has a functioning valve spring or whether the valve spring has been removed. Researchers assessing the outcomes will not know the arm to which the subject was randomized.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Sham Comparator 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. |
|
Recruiting Locations
Milwaukee, Wisconsin 53226
Stephanie Stevens, MS
More Details
- NCT ID
- NCT03916809
- Status
- Recruiting
- Sponsor
- University of Wisconsin, Milwaukee
Detailed Description
Thirty (30) persons with newly-diagnosed HNCA who will be treated with RT/CRT will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function. The training program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks, coincident with RT/CRT. Patients randomized to the Active EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Those randomized to the Sham EMST group will use an EMST150 device that has been modified to eliminate resistance to airflow. 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.