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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Other: Educational Intervention; Other: Exercise Intervention; Other: Expiratory Muscle Strength Training

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 78 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Undergo therapy session conducted by a speech pathologist; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform prescribed home exercises
EXPERIMENTAL: 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	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Undergo therapy session conducted by a speech pathologist; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Exercise Intervention; Perform prescribed home exercises; Other: Expiratory Muscle Strength Training; Participate in EMST; Other Names: EMST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Assessment Tool-10	Collected variables will be estimated through patient and clinician surveys.	Up to 1 year
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
Functional Oral Intake Scale (FOIS)	Collected variables will be estimated through patient and clinician surveys.	Up to 1 year
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Loni Arrese, PhD, SLP, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2016
• Primary Completion (ACTUAL): January 3, 2019
• Study Completion (ACTUAL): January 3, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: OSU-16023; NCI-2017-00848 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No