Digestive System Diseases

Ear, Nose, and Throat Diseases

All Conditions

Neoplasms

Mouth and Tooth Diseases

Deglutition Disorders

Pharyngeal Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Stomatognathic Diseases

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.

Standard of care therapy plus the addition of the IOPI instrument

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

Iowa Oral Performance Instrument

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.

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)

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.

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.

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

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.

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.

Jonas Johnson

Professor and Chairman

No adverse events, as defined by the University of Pittsburgh Institutional Review Board, occurred during the course of this research.

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.

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

Traditional Therapy Only

Standard of care therapy plus the addition of the IOPI instrument

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

Traditional Therapy With IOPI

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Tongue Strength (kPa)

Information is reported for the 20 participants who have completed the study.

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.

Christine Harrison, Clinical Research Coordinator

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.

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

Tongue strength was measured pre- and post-treatment with the Iowa Oral performance Instrument which measures linguapalatal pressure/force generation in kilopascals of pressure.

Standard of care therapy plus the addition of the IOPI instrument

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

Tongue strength was measured pre- and post-treatment with the Iowa Oral performance Instrument which measures linguapalatal pressure/force generation in kilopascals of pressure.

Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device

Not all participants were evaluated using a modified barium swallow test. Reasons that a participant did not perform the MBS, would be safety (the clinician did not feel that is was safe for the participant to undergo the MBS) or not indicated (an MBS was not clinically indicated at that time). Only completed MBS tests were evaluated.

Airway Protection During Swallowing

Pyriform

Vallecula

While the Traditional Therapy Only and the Traditional Therapy with IOPI groups each contain n=10 participants, only 6 swallowing evaluations underwent evaluation for this particular measure.

Detailed swallowing evaluations were only performed in participants who were felt to be "safe" to undergo the evaluations.

Spots Global Cancer Trial Database for iowa oral performance instrument (iopi)