Dysphagia, Oral Pharyngeal Cancer
Conditions
Keywords
dysphagia, oral pharyngeal cancer, Iowa Oral Performance Instrument (IOPI), IOPI
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.
Interventions
the IOPI device is being used to increase tongue strength and endurance
Sponsors
Jonas Johnson
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device | 8 weeks | Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway Protection During Swallowing | 8 week | 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. |
| Change Over Time of Pharyngeal Residue After Swallowing | 8 week | 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. |
| Swallowing Impairment-Self Report | 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 |
| Swallowing Impairment | 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. |
| Swallowing Impairment-Objective | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 |
Baseline characteristics
| Characteristic | Traditional Therapy Only | Traditional Therapy With IOPI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Continuous | 62.7 years | 62 years | 62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 26 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
| Tongue Strength (kPa) | 44.5 kPa | 41.4 kPa | 42.95 kPa |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 10 |
| other Total, other adverse events | 0 / 16 | 0 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 10 |
Outcome results
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)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Therapy Only | Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device | 7.9 kPa |
| Traditional Therapy With IOPI | Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device | 5.1 kPa |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Therapy Only | Airway Protection During Swallowing | 4.875 score on a scale |
| Traditional Therapy With IOPI | Airway Protection During Swallowing | 4.56 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Traditional Therapy Only | Change Over Time of Pharyngeal Residue After Swallowing | Pyriform | .0160 units on a scale |
| Traditional Therapy Only | Change Over Time of Pharyngeal Residue After Swallowing | Vallecula | -.0268 units on a scale |
| Traditional Therapy With IOPI | Change Over Time of Pharyngeal Residue After Swallowing | Pyriform | .0105 units on a scale |
| Traditional Therapy With IOPI | Change Over Time of Pharyngeal Residue After Swallowing | Vallecula | -.0589 units on a scale |
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.
Time frame: 8 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Therapy Only | Swallowing Impairment | 31.1 score on a scale |
| Traditional Therapy With IOPI | Swallowing Impairment | 30.5 score on a scale |
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.
Time frame: 8 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Therapy Only | Swallowing Impairment-Objective | 5.5 score on a scale |
| Traditional Therapy With IOPI | Swallowing Impairment-Objective | 5.2 score on a scale |
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
Time frame: 8 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Traditional Therapy Only | Swallowing Impairment-Self Report | 14.4 score on scale |
| Traditional Therapy With IOPI | Swallowing Impairment-Self Report | 15.5 score on scale |