Recruiting

EMST

Sponsor:

University of Wisconsin, Milwaukee

Code:

NCT03916809

Conditions

Head and Neck Neoplasms

Deglutition Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EMST

Study Details

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).

Conditions

Head and Neck Neoplasms

Deglutition Disorders

Study ID

NCT03916809

Start date

Jul 12, 2017

Status verified date

Dec, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Barbara Pauloski, Ph.D.

4142296719pauloski@uwm.edu

Locations

Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

University of Wisconsin, Milwaukee

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Keywords

  • oropharyngeal cancer
  • laryngeal cancer
  • swallow
  • chemoradiation
  • expiratory muscle strength training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Wisconsin, Milwaukee on 2024-12-04.