Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Not Applicable

Terminated

• Conditions: Oral Pharyngeal Cancer; Dysphagia
• Interventions: Device: Iowa Oral Performance Instrument

• Registration Number: NCT02564887
• Lead Sponsor: Jonas Johnson

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 ca...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Study Start: 2016-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-09-06
• Results First Submitted: 2020-01-31
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Results First Posted: 2020-03-23
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Therapy Only	Iowa Oral Performance Instrument	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.
Traditional Therapy with IOPI	Iowa Oral Performance Instrument	Standard of care therapy plus the addition of the IOPI instrument

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Swallowing Impairment-Self Report	8 week	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
Airway Protection During Swallowing	8 week	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.; ...
Swallowing Impairment	8 week	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.
Change Over Time of Pharyngeal Residue After Swallowing	8 week	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.; ...
Swallowing Impairment-Objective	8 week	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.

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States