Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Dysphagia Clinical Trial

Official title:

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02564887
• Other study ID #: PRO15080566
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 6, 2019

Study information

• Verified date: March 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: September 6, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Oral Pharyngeal Cancer
• Pharyngeal Neoplasms

Intervention

Device:
• Iowa Oral Performance Instrument
the IOPI device is being used to increase tongue strength and endurance

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jonas Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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