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Spots Global Cancer Trial Database for EMST in Patients Undergoing CRT for HNCA

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Trial Identification

Brief Title: EMST in Patients Undergoing CRT for HNCA

Official Title: 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)

Study ID: NCT03916809

Interventions

EMST

Study Description

Brief 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Wisconsin Milwaukee, Milwaukee, Wisconsin, United States

Froedtert Hospital, Milwaukee, Wisconsin, United States

Contact Details

Name: Barbara Pauloski

Affiliation: University of Wisconsin, Milwaukee

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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