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

NCT02662907 | Active Not Recruiting FDA Device

• 2 other identifiers: 2015-0238NCI-2016-00174
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Post-radiotherapy H&N cancer survivors; Aspiration; Expiratory muscle strength training; EMST; Dysphagia therapy; Modified barium swallow; Neurocognitive exams; Questionnaires; Surveys; Digital Manometer

Outcome Measures

Primary Outcomes (1)

• Association Between Aspiration and Expiratory Function Using Expiratory Training in Post-Radiotherapy H&N Cancer Survivors

  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

Study Arms (2)

Aspirators Group

EXPERIMENTAL

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; Behavioral: Questionnaires; Device: Expiratory Muscle Strength Training (EMST) Device; Device: Digital Manometer; Behavioral: Neurocognitive Exams; Drug: Barium

Non-Aspirators Group

OTHER

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; Behavioral: Questionnaires; Behavioral: Neurocognitive Exams; Drug: Barium

Interventions

Barium Swallow PROCEDURE

Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device

Aspirators Group; Non-Aspirators Group

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Aspirators Group; Non-Aspirators Group

Expiratory Muscle Strength Training (EMST) Device 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.

Also known as: EMST

Aspirators Group

Digital Manometer DEVICE

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.

Aspirators Group

Neurocognitive Exams BEHAVIORAL

Participants given neurocognitive exams at baseline.

Aspirators Group; Non-Aspirators Group

Barium DRUG

Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.

Aspirators Group; Non-Aspirators Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• IRG: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires; Barium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Heavy; Metals

Study Officials

• Katherine A. Hutcheson, PHD, MS, BA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 26, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)