Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Jonas Johnson
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Traditional Therapy with IOPI
Standard of care therapy plus the addition of the IOPI instrument
Intervention: Iowa Oral Performance Instrument (Device)
Traditional Therapy Only
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.
Intervention: Iowa Oral Performance Instrument (Device)
Outcomes
Primary Outcomes
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
Time Frame: 8 weeks
Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)
Secondary Outcomes
- Airway Protection During Swallowing(8 week)
- Swallowing Impairment-Self Report(8 week)
- Swallowing Impairment(8 week)
- Change Over Time of Pharyngeal Residue After Swallowing(8 week)
- Swallowing Impairment-Objective(8 week)
Investigators
Jonas Johnson
Professor and Chairman
University of Pittsburgh