Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

NCT02564887 | Terminated Results

• 1 other identifier: PRO15080566
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Oral Pharyngeal Cancer

Keywords

dysphagia; oral pharyngeal cancer; Iowa Oral Performance Instrument (IOPI); IOPI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Airway Protection During Swallowing

  8 week

• Change Over Time of Pharyngeal Residue After Swallowing

  8 week

• Swallowing Impairment-Self Report

  8 week

• Swallowing Impairment

  8 week

• Swallowing Impairment-Objective

  8 week

Study Arms (2)

Traditional Therapy Only

OTHER

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

Traditional Therapy with IOPI

EXPERIMENTAL

Standard of care therapy plus the addition of the IOPI instrument

Device: Iowa Oral Performance Instrument

Interventions

Iowa Oral Performance Instrument DEVICE

the IOPI device is being used to increase tongue strength and endurance

Also known as: IOPI

Traditional Therapy Only; Traditional Therapy with IOPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.

You may not qualify if:

• unable to adhere to assigned therapy program due to cognitive deficits
• surgical treatment for head and neck cancer
• unable to give informed consent

Sponsors & Collaborators

• Jonas Johnson: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

Enrollment for the study was lower than anticipated. This may be attributed to decreased availability of dedicated research personnel trained in the use of the IOPI device. Greater resources are now available for future studies in this area.

Results Point of Contact

• Title: Christine Harrison, Clinical Research Coordinator
• Organization: University of Pittsburgh

harrisonta@upmc.edu

412-647-9665

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: January 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: September 6, 2019
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (1)