Dysphagia
Conditions
Brief summary
This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery
Detailed description
This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
Interventions
DRUGDexamethasone
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
DRUGSaline
Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded (participant and investigator)
Intervention model description
Randomized; double blinded (participant and investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective anterior approach to subaxial cervical spine (C3 - T1); * ages 18-80
Exclusion criteria
* Traumatic or tumor etiologies * undergoing anterior-posterior operations * neoplastic, or infectious conditions requiring surgery * a history of previous anterior cervical spine surgery * any patient requiring a halo vest * patients on chronic steroids * patients remaining intubated post-operatively (please see more under risks below) * less than 18 years of age * pregnant women * no phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Occurrence of Dysphagia -Bazaz Scale | Baseline to Day 1 | Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome. |
| Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | Baseline to Day 1 | Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms. |
| Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | Baseline to Day 1 | Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1; Dexamethasone Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery | 40 |
| Treatment 0; Placebo Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery | 38 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Treatment 1; Dexamethasone | Treatment 0; Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 31 Participants | 59 Participants |
| Age, Continuous | 56.53 years STANDARD_DEVIATION 10.99 | 55.53 years STANDARD_DEVIATION 9.09 | 56.04 years STANDARD_DEVIATION 10.06 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 40 | 1 / 38 |
| other Total, other adverse events | 25 / 40 | 30 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Day 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 2.17 score on a scale | Standard Deviation 2.01 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 3.27 score on a scale | Standard Deviation 1.88 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Day 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 2.25 score on a scale | Standard Deviation 2.02 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 3.16 score on a scale | Standard Deviation 1.98 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Week 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 1.61 score on a scale | Standard Deviation 1.76 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 2.06 score on a scale | Standard Deviation 1.62 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Week 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 1.03 score on a scale | Standard Deviation 1.52 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 1.24 score on a scale | Standard Deviation 1.57 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 3
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.16 score on a scale | Standard Deviation 0.54 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.47 score on a scale | Standard Deviation 1.03 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 12
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.26 score on a scale | Standard Deviation 0.74 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.24 score on a scale | Standard Deviation 0.7 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.95 score on a scale | Standard Deviation 1.35 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.62 score on a scale | Standard Deviation 1.06 |
Primary
Change in the Occurrence of Dysphagia -Bazaz Scale
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Time frame: Baseline to Month 6
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.28 score on a scale | Standard Deviation 0.88 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia -Bazaz Scale | 0.06 score on a scale | Standard Deviation 0.24 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Day 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 2.81 score on a scale | Standard Deviation 2.73 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 3.76 score on a scale | Standard Deviation 2.28 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Day 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 3.22 score on a scale | Standard Deviation 2.63 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 3.5 score on a scale | Standard Deviation 2.56 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Week 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 2.92 score on a scale | Standard Deviation 3.41 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 3.75 score on a scale | Standard Deviation 3.08 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Week 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 1.89 score on a scale | Standard Deviation 2.98 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 2.62 score on a scale | Standard Deviation 2.73 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 1.79 score on a scale | Standard Deviation 2.48 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 1.73 score on a scale | Standard Deviation 2.26 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 3
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.62 score on a scale | Standard Deviation 1.38 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.86 score on a scale | Standard Deviation 1.17 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 6
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.56 score on a scale | Standard Deviation 1.11 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.23 score on a scale | Standard Deviation 0.65 |
Primary
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Time frame: Baseline to Month 12
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.86 score on a scale | Standard Deviation 1.87 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ). | 0.82 score on a scale | Standard Deviation 1.64 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Day 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 11.89 score on a scale | Standard Deviation 10.28 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 17.49 score on a scale | Standard Deviation 8.86 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Day 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 11.89 score on a scale | Standard Deviation 10.86 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 15.73 score on a scale | Standard Deviation 10.87 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Week 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 8.22 score on a scale | Standard Deviation 9.88 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 9.89 score on a scale | Standard Deviation 9.88 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Week 2
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 4.53 score on a scale | Standard Deviation 7.5 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 5.70 score on a scale | Standard Deviation 7.97 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 1
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 3.95 score on a scale | Standard Deviation 6.83 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 2.65 score on a scale | Standard Deviation 4.56 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 3
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 0.97 score on a scale | Standard Deviation 2.32 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 1.28 score on a scale | Standard Deviation 2.21 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 6
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 0.83 score on a scale | Standard Deviation 1.62 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 0.65 score on a scale | Standard Deviation 2 |
Primary
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity & monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Time frame: Baseline to Month 12
Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1; Dexamethasone | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 2.09 score on a scale | Standard Deviation 4.86 |
| Treatment 0; Placebo | Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening. | 2.44 score on a scale | Standard Deviation 6.66 |