Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer
NCT ID: NCT03175289
Last Updated: 2019-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2016-09-29
2019-01-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (standard of care, home exercises)
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.
Best Practice
Undergo therapy session conducted by a speech pathologist
Educational Intervention
Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
Exercise Intervention
Perform prescribed home exercises
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (standard of care, home exercises, EMST)
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
Best Practice
Undergo therapy session conducted by a speech pathologist
Educational Intervention
Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
Exercise Intervention
Perform prescribed home exercises
Expiratory Muscle Strength Training
Participate in EMST
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Undergo therapy session conducted by a speech pathologist
Educational Intervention
Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
Exercise Intervention
Perform prescribed home exercises
Expiratory Muscle Strength Training
Participate in EMST
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgery, if required, must be limited to: diagnostic biopsy
Exclusion Criteria
* 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
19 Years
78 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Loni Arrese, PhD, SLP
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2017-00848
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16023
Identifier Type: -
Identifier Source: org_study_id
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