Clinical Trials Directory

Trials / Terminated

TerminatedNCT03975465

EMST and Swallowing in Long-Term Survivors of HNCA

Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Wisconsin, Milwaukee · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExpiratory Muscle Strength Training8 weeks of EMST at 75% maximum expiratory pressure (MEP)
BEHAVIORALPharyngeal Muscle Strengthening Exercises8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing

Timeline

Start date
2018-09-10
Primary completion
2024-06-04
Completion
2024-06-04
First posted
2019-06-05
Last updated
2024-12-06

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03975465. Inclusion in this directory is not an endorsement.