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

NCT02662907 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-04-16

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • IRG

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Katherine A. Hutcheson, PHD, MS, BA · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2027-02-02
Completion
2027-02-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662907 on ClinicalTrials.gov