Clinical trial · Interventional
EMST and Swallowing in Long-Term Survivors of HNCA
Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accruals
Summary
Brief summary (as posted)
This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deglutition Disorders | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expiratory Muscle Strength Training | Behavioral | — | UNRESOLVED |
| Pharyngeal Muscle Strengthening Exercises | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Expiratory Muscle Strength Training
- description
- Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions
- interventionNames
- Behavioral: Expiratory Muscle Strength Training
- type
- ACTIVE_COMPARATOR
- label
- Pharyngeal Muscle Strengthening Exercises
- description
- Patients randomized to Standard Care will receive swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion
- interventionNames
- Behavioral: Pharyngeal Muscle Strengthening Exercises
Primary outcomes (7)
- measure
- Level of Oral Intake (number)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment; 2. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies; 3. Ability to follow directions and engage in a program of rehabilitation Exclusion Criteria: 1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke); 2. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.
References
Publications (0)
Data not yet available