Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy

October 5, 2023 updated by: M.D. Anderson Cancer Center
The goal of this clinical research study is to learn if exercising the muscles that help you cough and swallow, called expiratory muscle strength training (EMST), can help reduce the risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients who have had radiation for head and neck cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Visits:

If you are found to be eligible and you agree to take part in the therapeutic portion of the EMST therapy study, you will be trained how to use the EMST device. This device is designed to help strengthen the muscles used for swallowing and coughing. To use this small handheld device, you will wear a nose clip to prevent air from coming out of your nose. You will be asked to sit upright and take a deep breath, hold your breath for a moment, and then blow forcefully into the device until you break the seal.

You will use the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks. Using the EMST device should take about 15 minutes each day you train.

One (1) time each week during these 8 weeks, you will meet with a speech pathologist in the Head and Neck Center at MD Anderson. At each visit, you will use the digital manometer to re-test how forcefully you are able to exhale and cough. The resistance of the EMST device will be adjusted based on each week's measurement.

Length of Study:

You will be on study for up to 12 months. Your study participation will be over after the follow-up call, described below. You will be taken off study early if you are unable to use the EMST device, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.

Follow-Up Visit:

After 8 weeks of using the EMST device, you will have a follow-up visit.

  • You will have the same functional testing you had at screening (the modified barium swallow and tests of your tongue strength, mouth opening, and ability to exhale and cough forcefully).
  • You will complete the questionnaires and will be asked about your symptoms and quality of life.

Follow-Up Call:

You will be contacted by phone 12 months after you joined the study to complete 4 questionnaires about your symptoms, health and quality of life. This call should take up to 15 minutes.

This is an investigational study. The EMST device is FDA approved for exercising the muscles used in coughing and swallowing. Its use in preventing aspiration in patients who have received radiation for head and neck cancer is considered investigational.

Up to 300 patients will be enrolled in this study. All will take part at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >/= 18 years
  2. History of curative-intent radiotherapy at MDACC for a new primary H&N cancer in past 15 years
  3. Referred to Section of Speech Pathology and Audiology for swallowing evaluation
  4. Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

  1. History of recurrent or second primary H&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
  2. Prior H&N surgery excluding diagnostic procedures, transoral surgery, or non-radical neck dissection
  3. History of functionally limiting chronic or acute cardiac, pulmonary, or neuromuscular disease
  4. Tracheotomy or oxygen dependence at time of MBS
  5. Patients with Mini-Mental State Examination (MMSE) <24 will be ineligible for participation in the therapeutic trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirators Group

Participants receive modified barium swallow at baseline and after 8 weeks of using the expiratory muscle strength training (EMST) device. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.

Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks.

Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device.
Procedure: Barium Swallow
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
Behavioral: Questionnaires
Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.
Other Names:
  • Surveys
Device: Expiratory Muscle Strength Training (EMST) Device
Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks.
Other Names:
  • EMST
Device: Digital Manometer
Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device.
Behavioral: Neurocognitive Exams
Participants given neurocognitive exams at baseline.
Drug: Barium
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
Other: Non-Aspirators Group
Participants receive modified barium swallow at baseline. Participants given neurocognitive exams at baseline. Questionnaires completed about symptoms and quality of life at baseline and at 12 months.
Procedure: Barium Swallow
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
Behavioral: Questionnaires
Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.
Other Names:
  • Surveys
Behavioral: Neurocognitive Exams
Participants given neurocognitive exams at baseline.
Drug: Barium
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors
Time Frame: 12 months
Primary analysis is association between baseline Penetration-Aspiration Scale (PAS) scores and baseline maximum expiratory pressures (MEPs). Analysis examined by plotting the data and computing a polyserial correlation coefficient. Participants with PAS≥6 coded as aspirators.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

IRG

Investigators

  • Principal Investigator: Katherine A. Hutcheson, PHD, MS, BA, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimated)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0238
  • NCI-2016-00174 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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