EMST and Swallowing in Long-Term Survivors of HNCA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Neoplasms, Deglutition Disorders

Intervention / Treatment
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* Behavioral: Expiratory Muscle Strength Training
* Behavioral: Pharyngeal Muscle Strengthening Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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; Ability to follow directions and engage in a program of rehabilitation Exclusion Criteria: the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke); 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to an 8-week program of either Expiratory Muscle Strength Training (EMST) or Standard Care in order to examine the impact of EMST on swallowing function
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expiratory Muscle Strength Training<br>Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions | Behavioral: Expiratory Muscle Strength Training<br>* 8 weeks of EMST at 75% maximum expiratory pressure (MEP)<br>|
| Active Comparator: Pharyngeal Muscle Strengthening Exercises<br>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 | Behavioral: Pharyngeal Muscle Strengthening Exercises<br>* 8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Oral Intake (number) | 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). | 8 weeks | 
| Maximum Expiratory Pressure (MEP) cm H20 | Change in maximum expiratory pressure level will be calculated from baseline to post-treatment. | 8 weeks | 
| Extent of hyoid movement (mm) | From Videofluoroscopic Swallow Studies (VFSS), the change in extent of hyoid movement in mm will be determined from baseline to post-treatment. | 8 weeks | 
| Upper esophageal sphincter (UES) opening width (mm) | From Videofluoroscopic Swallow Studies (VFSS), the change in width of UES opening width in mm will be determined from baseline to post-treatment. | 8 weeks | 
| Presence of pharyngeal residue (dichotomous) | From Videofluoroscopic Swallow Studies (VFSS), the presence of residue in the pharynx (yes or no) will be determined from baseline to post-treatment. | 8 weeks | 
| Penetration-Aspiration Scale rating (number) | 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) | 8 weeks | 
| Timing of Aspiration (category) | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training, long-term survivor