Clinical trial · Interventional
Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment goals not met in efficient timeframe.
Summary
Brief summary (as posted)
Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.
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 |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Oral Pharyngeal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iowa Oral Performance Instrument | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Traditional Therapy Only
- description
- Standard of care therapy for qualifying population (with opportunity to "crossover" and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion.
- interventionNames
- Device: Iowa Oral Performance Instrument
- type
- EXPERIMENTAL
- label
- Traditional Therapy with IOPI
- description
- Standard of care therapy plus the addition of the IOPI instrument
- interventionNames
- Device: Iowa Oral Performance Instrument
Primary outcomes (1)
- measure
- Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia. Exclusion Criteria: * unable to adhere to assigned therapy program due to cognitive deficits * surgical treatment for head and neck cancer * unable to give informed consent
References
Publications (0)
Data not yet available