Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 19 - 78 |
| Updated: | 12/16/2017 |
| Start Date: | September 29, 2016 |
| End Date: | June 2019 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCClinicaltrials@osumc.edu |
| Phone: | 1-800-293-5066 |
The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
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.
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.
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.
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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Loni Arrese, PhD, SLP
Phone: 614-293-7442
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