The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Head and Neck Neoplasm
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Airway safety during swallowing assessed using the Penetration-Aspiration Scale
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Airway safety during swallowing assessed using the Penetration-Aspiration Scale
Time Frame: Up to 1 year
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.
Secondary Outcomes
- Eating Assessment Tool-10(Up to 1 year)
- Expiratory flow assessed using portable digital peak flow meter(Up to 1 year)
- Functional Oral Intake Scale (FOIS)(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(Up to 1 year)
- Maximum expiratory pressure assessed using the MicroRPM pressure meter(Up to 1 year)
- Maximum mandibular opening using the TheraBite range of motion scale(Up to 1 year)
- Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(Up to 1 year)
- Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study(Up to 1 year)
- Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile(Up to 1 year)