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

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ClinicalTrials.gov Identifier: NCT03175289
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Loni Arrese, Ohio State University Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Head and Neck Neoplasm Other: Best Practice Other: Educational Intervention Other: Exercise Intervention Other: Expiratory Muscle Strength Training Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
Actual Study Start Date : September 29, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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: 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: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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: 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 Name: EMST

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175289


Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Loni Arrese, PhD, SLP    614-293-7442    Loni.Arrese@osumc.edu   
Principal Investigator: Loni Arrese, PhD, SLP         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Loni Arrese, PhD, SLP Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: Loni Arrese, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03175289     History of Changes
Other Study ID Numbers: OSU-16023
NCI-2017-00848 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms