EMST in Patients Undergoing CRT for HNCA
Start Date
7/12/2017
Completion Date
8/1/2025
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).
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
EMST
Conditions
Locations
University of Wisconsin Milwaukee
Milwaukee, Wisconsin 53211
United States
Froedtert Hospital
Milwaukee, Wisconsin 53226
United States