Trial Outcomes & Findings for Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy (NCT NCT02564887)

NCT ID: NCT02564887

Last Updated: 2020-03-23

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-03-23

Participant Flow

Participant milestones

Measure	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. Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance	Traditional Therapy With IOPI 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
Overall Study STARTED	16	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Measure	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. Iowa Oral Performance Instrument: the IOPI device is being used to increase tongue strength and endurance	Traditional Therapy With IOPI 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
Overall Study Lost to Follow-up	6	0

Baseline Characteristics

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Baseline characteristics by cohort

Measure	Traditional Therapy Only n=10 Participants 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 With IOPI n=10 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	62.7 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	26 participants n=5 Participants
Tongue Strength (kPa)	44.5 kPa n=5 Participants	41.4 kPa n=7 Participants	42.95 kPa n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Traditional Therapy Only n=10 Participants 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.	Traditional Therapy With IOPI n=10 Participants 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	7.9 kPa Interval 0.0 to 13.0	5.1 kPa Interval -4.0 to 23.0

SECONDARY outcome

Timeframe: 8 week

Population: 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.

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.

Outcome measures

Measure	Traditional Therapy Only n=4 Participants 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.	Traditional Therapy With IOPI n=9 Participants 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.
Airway Protection During Swallowing	4.875 score on a scale Interval 2.0 to 6.5	4.56 score on a scale Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: 8 week

Population: 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.

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.

Outcome measures

Measure	Traditional Therapy Only n=6 Participants 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.	Traditional Therapy With IOPI n=6 Participants 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.
Change Over Time of Pharyngeal Residue After Swallowing Pyriform	.0160 units on a scale Interval -0.0013 to 0.0587	.0105 units on a scale Interval -0.0001 to 0.031
Change Over Time of Pharyngeal Residue After Swallowing Vallecula	-.0268 units on a scale Interval -0.0431 to 0.0131	-.0589 units on a scale Interval -0.2007 to 0.03

SECONDARY outcome

Timeframe: 8 week

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

Outcome measures

Measure	Traditional Therapy Only n=10 Participants 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.	Traditional Therapy With IOPI n=10 Participants 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.
Swallowing Impairment-Self Report	14.4 score on scale Interval 3.0 to 24.0	15.5 score on scale Interval 3.0 to 34.0

SECONDARY outcome

Timeframe: 8 week

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.

Outcome measures

Measure	Traditional Therapy Only n=10 Participants 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.	Traditional Therapy With IOPI n=10 Participants 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.
Swallowing Impairment	31.1 score on a scale Interval 5.0 to 60.0	30.5 score on a scale Interval 0.0 to 80.0

SECONDARY outcome

Timeframe: 8 week

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.

Outcome measures

Measure	Traditional Therapy Only n=10 Participants 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.	Traditional Therapy With IOPI n=10 Participants 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.
Swallowing Impairment-Objective	5.5 score on a scale Interval 2.0 to 7.0	5.2 score on a scale Interval 2.0 to 7.0

Adverse Events

Traditional Therapy Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Therapy With IOPI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Harrison, Clinical Research Coordinator

University of Pittsburgh

Phone: 412-647-9665

Email: harrisonta@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place