Expiratory Muscle Strength Training in Improving Bulbar Function & Quality

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03175289
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	September 29, 2016
Completion date	January 3, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms