Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Conditions
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Dysphagia, Oral Pharyngeal Cancer

Intervention / Treatment
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* Device: Iowa Oral Performance Instrument


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional Therapy Only<br>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. | Device: Iowa Oral Performance Instrument<br>* the IOPI device is being used to increase tongue strength and endurance<br>* Other names: IOPI;|
| Experimental: Traditional Therapy with IOPI<br>Standard of care therapy plus the addition of the IOPI instrument | Device: Iowa Oral Performance Instrument<br>* the IOPI device is being used to increase tongue strength and endurance<br>* Other names: IOPI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device | Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Protection During Swallowing | Penetration-aspiration scale score of the modified barium swallow (MBS) data for small, thin liquids Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Minimum 1 Maximum 8 Lower is better The score being evaluated is an absolute score at the time of collection and not the change over time. | 8 week | 
| Change Over Time of Pharyngeal Residue After Swallowing | The change in pharyngeal retention measured using the normalized residue ratio scale (NRR) is being assessed. The NRR quantifies the amount of residue remaining in the valleculae and pyriform sinuses after a swallow as a ratio of the total area of each of these two pharyngeal spaces. Value represents the area of space that is occupied by barium at the end of a swallow. The change from baseline to 8 weeks is documented. A positive change (+) is worsening of symptoms. A negative change (-) is bettering of symptoms. | 8 week | 
| Swallowing Impairment-Self Report | Patient perceived outcome measure related to their view of their swallowing problem/difficulties at that point in time. Eating Assessment Tool (EAT-10). Minimum score 0 Maximum score 40 Higher score is worse Number reported is final overall score | 8 week | 
| Swallowing Impairment | visual analog scale related to patient perceived swallowing impairment at that point in time. Minimum - 0 Maximum - 100 Higher is worse Score reported is the overall score at that time and not a change from baseline. | 8 week | 
| Swallowing Impairment-Objective | functional oral intake scale (FOIS) The Functional Oral Intake Scale is an ordinal scale that is used to assess the current status and meaningful change in the oral intake. Minimum - 1 Maximum - 7 Higher is better Score reported is the overall score at that point in time and not a change from baseline. | 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysphagia, oral pharyngeal cancer, Iowa Oral Performance Instrument (IOPI), IOPI