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

Malignant Head and Neck Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175289
• Other study ID #: OSU-16023
• Secondary ID: NCI-2017-00848
• Status: Completed
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: January 3, 2019

Study information

• Verified date: May 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Malignant Head and Neck Neoplasm

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway safety during swallowing assessed using the Penetration-Aspiration Scale	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.	Up to 1 year
Secondary	Eating Assessment Tool-10	Collected variables will be estimated through patient and clinician surveys.	Up to 1 year
Secondary	Expiratory flow assessed using portable digital peak flow meter	Exploratory mixed effect model will be used to investigate respiratory measures 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.	Up to 1 year
Secondary	Functional Oral Intake Scale (FOIS)	Collected variables will be estimated through patient and clinician surveys.	Up to 1 year
Secondary	Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument	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.	Up to 1 year
Secondary	Maximum expiratory pressure assessed using the MicroRPM pressure meter	Exploratory mixed effect model will be used to investigate respiratory measures 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.	Up to 1 year
Secondary	Maximum mandibular opening using the TheraBite range of motion scale	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.	Up to 1 year
Secondary	Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire	Exploratory mixed effect model will be used to investigate quality of life 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.	Up to 1 year
Secondary	Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study	Logistic regression method will be used to explore associations between treatment and respiratory-swallow phase (normal/abnormal).	Up to 1 year
Secondary	Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile	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.	Up to 1 year

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