Clinical trial · Interventional
Cough, Expiratory Training, and Chronic Aspiration After Head and Neck Radiotherapy
NCT02662907CI-TRIAL-00108454active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Barium | Drug | — | UNRESOLVED |
| Barium Swallow | Procedure | — | UNRESOLVED |
| Digital Manometer | Device | — | UNRESOLVED |
| Expiratory Muscle Strength Training (EMST) Device | Device | — | UNRESOLVED |
| Neurocognitive Exams | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aspirators Group
- description
- 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.
- interventionNames
- Procedure: Barium Swallow
- Behavioral: Questionnaires
- Device: Expiratory Muscle Strength Training (EMST) Device
- Device: Digital Manometer
- Behavioral: Neurocognitive Exams
- Drug: Barium
- type
- OTHER
- label
- Non-Aspirators Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.