Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Jonas Johnson26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dysphagia Oral Pharyngeal Cancer

Interventions

Iowa Oral Performance InstrumentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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)

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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