Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Investigate the impact of a prophylactic targeted exercise program, expiratory muscle strength training (EMST), on swallowing function and well-being of individuals on head and neck cancer (HNC). II. Determine the impact of EMST on objective respiratory measures of individuals with HNC. III. Determine the relationship between mean dose across the swallowing muscles (oral tongue and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors, proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions. ARM II: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy. After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Official Title
-----------------
The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer

Conditions
-----------------
Malignant Head and Neck Neoplasm

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Educational Intervention
* Other: Exercise Intervention
* Other: Expiratory Muscle Strength Training
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a definitive, curative treatment plan consisting of chemoradiation for head & neck cancer Surgery, if required, must be limited to: diagnostic biopsy Exclusion Criteria: Participants enrolled in a radiation de-intensification protocol Current or previous neurological disease, which may adversely affect swallowing History of oropharyngeal swallowing disorder prior to cancer diagnosis Previous neurosurgery on the brain Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care, home exercises)<br>Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions. | Other: Best Practice<br>* Undergo therapy session conducted by a speech pathologist<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform prescribed home exercises<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (standard of care, home exercises, EMST)<br>Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy | Other: Best Practice<br>* Undergo therapy session conducted by a speech pathologist<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus<br>* Other names: Intervention, Educational;Other: Exercise Intervention<br>* Perform prescribed home exercises<br>Other: Expiratory Muscle Strength Training<br>* Participate in EMST<br>* Other names: EMST;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway safety during swallowing assessed using the Penetration-Aspiration Scale | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Assessment Tool-10 | Collected variables will be estimated through patient and clinician surveys. | Up to 1 year | 
| Expiratory flow assessed using portable digital peak flow meter | Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year | 
| Functional Oral Intake Scale (FOIS) | Collected variables will be estimated through patient and clinician surveys. | Up to 1 year | 
| Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year | 
| Maximum expiratory pressure assessed using the MicroRPM pressure meter | Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year | 
| Maximum mandibular opening using the TheraBite range of motion scale | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year | 
| Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire | Exploratory mixed effect model will be used to investigate quality of life with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. | Up to 1 year | 
| Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study | Logistic regression method will be used to explore associations between treatment and respiratory-swallow phase (normal/abnormal). | Up to 1 year | 
| Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile | Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures. | Up to 1 year |