EMST and Swallowing in Long-Term Survivors of HNCA

Last updated: December 3, 2024
Sponsor: University of Wisconsin, Milwaukee
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Expiratory Muscle Strength Training

Pharyngeal Muscle Strengthening Exercises

Clinical Study ID

NCT03975465
PRO32538
  • Ages > 18
  • All Genders

Study Summary

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx,or for an unknown primary at least 5 years prior to enrollment. Subjects may havehad surgery as long as a minimum dose of 50 Gy of radiation was part of thetreatment;

  2. Subject must have a current swallow complaint or impairment; these include but arenot limited to reduced oral intake, perceived difficulty with bolus transport (e.g.feeling of food sticking in throat); aspiration on various bolus consistencies;

  3. Ability to follow directions and engage in a program of rehabilitation

Exclusion

Exclusion Criteria:

  1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g.cognitive impairment, history of stroke);

  2. the subject presents with contraindications for EMST as specified in the EMST150package insert unless cleared for participation by the subject's physician. Theseconditions include untreated hypertension, untreated gastroesophageal reflux diseas,recent stroke, lung disease, and pregnancy.

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Expiratory Muscle Strength Training
Phase:
Study Start date:
September 10, 2018
Estimated Completion Date:
June 04, 2024

Study Description

Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks.

All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.

Connect with a study center

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • University of Wisconsin Milwaukee

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

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