EMST and Swallowing in Long-Term Survivors of HNCA

Not Applicable

Terminated

• Conditions: Head and Neck Neoplasms; Deglutition Disorders
• Interventions: Behavioral: Pharyngeal Muscle Strengthening Exercises; Behavioral: Expiratory Muscle Strength Training

• Registration Number: NCT03975465
• Lead Sponsor: University of Wisconsin, Milwaukee

Brief 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.

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2019-06-01
• Study First Submitted QC: 2019-06-01
• Study First Posted: 2019-06-05
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;
2. Subject must have a current swallow complaint or impairment; these include but are not 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 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 EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharyngeal Muscle Strengthening Exercises	Pharyngeal Muscle Strengthening Exercises	Patients randomized to Standard Care will receive swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion
Expiratory Muscle Strength Training	Expiratory Muscle Strength Training	Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions

Primary Outcome Measures

Name	Time	Method
Maximum Expiratory Pressure (MEP) cm H20	8 weeks	Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.
Upper esophageal sphincter (UES) opening width (mm)	8 weeks	From Videofluoroscopic Swallow Studies (VFSS), the change in width of UES opening width in mm will be determined from baseline to post-treatment.
Extent of hyoid movement (mm)	8 weeks	From Videofluoroscopic Swallow Studies (VFSS), the change in extent of hyoid movement in mm will be determined from baseline to post-treatment.
Level of Oral Intake (number)	8 weeks	Change in Food Level and Drink Level on International Dysphagia Diet Standardisation Initiative (IDDSI) scale will be calculated from baseline to post-treatment.; IDDSI scale rates the level of liquid or food that the person can eat. Scale values range from 0 to 7, with higher values indicating better outcome (greater ability to eat).
Timing of Aspiration (category)	8 weeks	From Videofluoroscopic Swallow Studies (VFSS), timing of aspiration will be determined from baseline to post-treatment. Timing is identified as a category, either before, during, or after.
Presence of pharyngeal residue (dichotomous)	8 weeks	From Videofluoroscopic Swallow Studies (VFSS), the presence of residue in the pharynx (yes or no) will be determined from baseline to post-treatment.
Penetration-Aspiration Scale rating (number)	8 weeks	From Videofluoroscopic Swallow Studies (VFSS), change in the Penetration-Aspiration Scale (PAS) score will be determined from baseline to post-treatment. Penetration-Aspiration Scale is an 8-point ordinal rating scale that rates the depth to which food or liquid invades the airway. Values range from a minimum of 1 to a maximum of 8; higher values represent worse outcome (i.e. greater depth of invasion into the airway)

Trial Locations

Locations (2)

University of Wisconsin Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States