EMST in Patients Undergoing CRT for HNCA

Last updated: December 3, 2024
Sponsor: University of Wisconsin, Milwaukee
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

EMST

Clinical Study ID

NCT03916809
PRO29168
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 lateralsclerosis (ALS), Parkinson's disease)

  • Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke orpost--traumatic brain injury (TBI))

  • Prior history of head and neck radiotherapy

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: EMST
Phase:
Study Start date:
July 12, 2017
Estimated Completion Date:
August 01, 2025

Study 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.

Connect with a study center

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • University of Wisconsin Milwaukee

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

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