EMST in Patients Undergoing CRT for HNCA

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
University of Wisconsin, Milwaukee
Study ID
NCT03916809
Status
Recruiting
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Conditions

  • Deglutition Disorders
  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMST — OTHER
    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.

Study Details

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).

Key Dates

Start date
Jul 12, 2017
Status verified
Dec 2024
Primary completion
Aug 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feeding-tube-free food intake (days) [ Time Frame: 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Froedtert HospitalMilwaukeeWisconsin53226
Stephanie Stevens, MS
University of Wisconsin MilwaukeeMilwaukeeWisconsin53211-

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Froedtert Hospital· Milwaukee, WIUniversity of Wisconsin Milwaukee· Milwaukee, WI

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