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Completed

NCT Number: NCT03175289

Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients 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.

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Key information

Conditions

Malignant Head and Neck Neoplasm Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

19 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Undergo therapy session conducted by a speech pathologist

Other names: standard of care, standard therapy

Educational Intervention

Other

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

Exercise intervention

Other

Perform prescribed home exercises

Expiratory Muscle Strength Training

Other

Participate in EMST

Other names: EMST

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Airway safety during swallowing assessed using the Penetration-Aspiration Scale

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. Eating Assessment Tool-10

    Time frame: Up to 1 year

    Collected variables will be estimated through patient and clinician surveys.

  2. Expiratory flow assessed using portable digital peak flow meter

    Time frame: Up to 1 year

    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.

  3. Functional Oral Intake Scale (FOIS)

    Time frame: Up to 1 year

    Collected variables will be estimated through patient and clinician surveys.

  4. Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument

    Time frame: Up to 1 year

    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.

  5. Maximum expiratory pressure assessed using the MicroRPM pressure meter

    Time frame: Up to 1 year

    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.

  6. Maximum mandibular opening using the TheraBite range of motion scale

    Time frame: Up to 1 year

    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.

  7. Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

    Time frame: Up to 1 year

    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.

  8. Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study

    Time frame: Up to 1 year

    Logistic regression method will be used to explore associations between treatment and respiratory-swallow phase (normal/abnormal).

  9. Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile

    Time frame: Up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2017
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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