Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

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 Overview

• Status: Terminated
• Conditions: Dysphagia; Oral Pharyngeal Cancer
• Intervention / Treatment: Device: Iowa Oral Performance Instrument

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jonas Johnson

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: dysphagia; oral pharyngeal cancer; Iowa Oral Performance Instrument (IOPI); IOPI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Pharyngeal Neoplasms
• Other Study ID Numbers: PRO15080566