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Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377270
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Edward Hines Jr. VA Hospital
Medical University of South Carolina
University of South Alabama
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Veterans following treatment of head and neck cancer can be left with lasting swallowing impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia. The investigators' previous trial tested a new swallowing treatment approach to target respiratory-swallow coordination. The results revealed improvements in respiratory-swallow coordination and swallowing function. The goal of this study is to determine the impact and durability of respiratory-swallow training (RST) on clinical outcomes necessary for eating, drinking, health, and quality-of-life in Veterans with swallowing impairment following treatment for head and neck cancer. A total of 88 participants will be recruited and randomly assigned to the RST or standard of care. An additional 11 participants will be recruited to RST plus a home practice portion to obtain preliminary data regarding efficacy of home practice.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dysphagia Behavioral: Respiratory Swallow Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized-controlled trial with 2 arms (intervention and control)
Masking: Single (Outcomes Assessor)
Masking Description: outcomes assessor (those completed the swallow studies, those scoring)
Primary Purpose: Treatment
Official Title: Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in OP HNC
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RST
Respiratory Swallow Training Arm
Behavioral: Respiratory Swallow Training
Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation

No Intervention: Standard of Care
Standard of Care Arm
Home Practice Arm
RST + Home Practice Arm
Behavioral: Respiratory Swallow Training
Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation




Primary Outcome Measures :
  1. Change in MBSImP physiologic function metrics of the oropharyngeal swallow [ Time Frame: Baseline, 30 days, 60 days, 120 days, 240 days ]
    Measures oral intake status and tolerance


Secondary Outcome Measures :
  1. Penetration Aspiration scale [ Time Frame: Baseline, 30 days, 60 days, 120 days, 240 days ]
    Measure presence, depth and reaction to penetration and aspiration

  2. MD Anderson Dysphagia Index [ Time Frame: Baseline, 30 days, 60 days, 120 days, 240 days ]
    Swallow specific quality of life

  3. Performance status scale for head and neck cancer [ Time Frame: Baseline, 30 days, 60 days, 120 days, 240 days ]
    Measures performance in normalcy of diet, eating in public and understandability of speech

  4. Functional Oral Intake Scale (FOIS) [ Time Frame: Baseline, 30 days, 60 days, 120 days, 240 days ]
    Measures oral intake



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran and non Veterans
  • have undergone treatment for a primary diagnosis of head and neck cancer (oral cavity, oropharyngeal, and hypopharyngeal)
  • are 21 years of age
  • 6 months post head and neck cancer treatment
  • 6 months post-traditional swallowing treatment with continued dysphagia
  • English speaking
  • pass a cognitive screening (score 26 on the Montreal Cognitive Assessment (MoCA)
  • do not present with severe chronic obstructive pulmonary disease (COPD) based on pulmonary function testing (PFT)
  • drink less than 2 alcoholic beverages per day

Exclusion Criteria:

  • if they have known allergy or dietary restriction for contrast materials or liquids used during the MBSS or training
  • currently drinking greater than two drinks per day
  • severe COPD
  • are unable to swallow one liquid consistency without the use of a compensatory strategy or swallow maneuver without aspiration
  • history of aspiration pneumonia within the past 12 months

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): NCT03377270


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
Edward Hines Jr. VA Hospital
Medical University of South Carolina
University of South Alabama
Investigators
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Principal Investigator: Bonnie J. Martin-Harris, PhD Edward Hines Jr. VA Hospital, Hines, IL
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03377270    
Other Study ID Numbers: F2352-R
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All participants' data will be de-identified and aggregated for analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Oropharyngeal Head and Neck Cancer
dysphagia
Respiratory Swallow Training
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases