Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy
NCT ID: NCT02662907
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
175 participants
INTERVENTIONAL
2016-02-01
2027-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
NCT03620084
Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer
NCT05787834
Resistance Inspiratory Muscle Training for Patients With Thoracic Malignancies
NCT03834116
The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke
NCT06267768
Exercise After Radiation for Head & Neck Cancer
NCT04013178
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Barium Swallow
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
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.
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.
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.
Neurocognitive Exams
Participants given neurocognitive exams at baseline.
Barium
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
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.
Barium Swallow
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
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.
Neurocognitive Exams
Participants given neurocognitive exams at baseline.
Barium
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Barium Swallow
Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
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.
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.
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.
Neurocognitive Exams
Participants given neurocognitive exams at baseline.
Barium
Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRG
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katherine A. Hutcheson, PHD, MS, BA
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-00174
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0238
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.