Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment goals not met in efficient timeframe.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Traditional Therapy with IOPI | Experimental | Standard of care therapy plus the addition of the IOPI instrument |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iowa Oral Performance Instrument | Device | the IOPI device is being used to increase tongue strength and endurance |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Information is reported for the 20 participants who have completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Full Range | kPa | 8 weeks |
|
2 years, 8 months
No adverse events, as defined by the University of Pittsburgh Institutional Review Board, occurred during the course of this research.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Harrison, Clinical Research Coordinator | University of Pittsburgh | 412-647-9665 | harrisonta@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2017 | Jan 29, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 | Jan 29, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tongue Strength (kPa) | Mean | Full Range | kPa |
|
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. |
|
|
| Secondary | 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. | 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. | Posted | Mean | Full Range | score on a scale | 8 week |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Full Range | units on a scale | 8 week |
|
|
|
| Secondary | 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 | Posted | Mean | Full Range | score on scale | 8 week |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | 8 week |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | 8 week |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D010038 | Otorhinolaryngologic Diseases |