NCT03175289

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Head and Neck Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo therapy session conducted by a speech pathologist
OTHER	Educational Intervention	Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
OTHER	Exercise Intervention	Perform prescribed home exercises
OTHER	Expiratory Muscle Strength Training	Participate in EMST
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-09-29
• Primary completion: 2019-01-03
• Completion: 2019-01-03
• First posted: 2017-06-05
• Last updated: 2019-05-21

Locations

1 site across 1 country: United States