Trial Outcomes & Findings for Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer (NCT NCT01748942)
NCT ID: NCT01748942
Last Updated: 2018-06-19
Results Overview
Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating "No pain" and 10 indicating "Worst possible, unbearable, excruciating pain". A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
21 days
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Arm I (Treatment)
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Continuous
|
56 years
n=93 Participants
|
60 years
n=4 Participants
|
58 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=93 Participants
|
33 participants
n=4 Participants
|
68 participants
n=27 Participants
|
|
VAS pain score
|
1.1 units on a scale
STANDARD_DEVIATION 1.8 • n=93 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 1.6 • n=27 Participants
|
|
Tumor stage
T1
|
21 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Tumor stage
T2
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
EAT-10 score
|
5.9 units on a scale
STANDARD_DEVIATION 7.6 • n=93 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 6.2 • n=4 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 6.9 • n=27 Participants
|
|
PSS normalcy of diet
|
92.3 units on a scale
STANDARD_DEVIATION 16.4 • n=93 Participants
|
94.2 units on a scale
STANDARD_DEVIATION 15.0 • n=4 Participants
|
93.8 units on a scale
STANDARD_DEVIATION 15.4 • n=27 Participants
|
|
UM-QOL eating score
|
89.6 units on a scale
STANDARD_DEVIATION 17.8 • n=93 Participants
|
93.75 units on a scale
STANDARD_DEVIATION 12.7 • n=4 Participants
|
89.6 units on a scale
STANDARD_DEVIATION 17.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: 21 daysVisual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating "No pain" and 10 indicating "Worst possible, unbearable, excruciating pain". A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups.
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Postoperative day #1
|
7.4 units on a scale
Standard Deviation 2.0
|
6.8 units on a scale
Standard Deviation 2.3
|
|
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Postoperative day #2
|
6.0 units on a scale
Standard Deviation 2.0
|
6.4 units on a scale
Standard Deviation 2.1
|
|
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Postoperative day #3
|
5.3 units on a scale
Standard Deviation 2.0
|
6.7 units on a scale
Standard Deviation 1.9
|
|
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Postoperative day #7-21
|
3.0 units on a scale
Standard Deviation 1.8
|
2.5 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Up to 30 daysA descriptive statistical analysis will be conducted on complications.
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Complications Associated With Postoperative Corticosteroid Use After TORS
complication present
|
10 Participants
|
7 Participants
|
|
Complications Associated With Postoperative Corticosteroid Use After TORS
no complication
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsStatistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = "No problem" and 4= "Severe problem". A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups.
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Eating Assessment Tool (EAT)-10 Scores
|
20.0 units on a scale
Standard Deviation 8.3
|
20.2 units on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Up to 21 daysKaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
|
5 days
Standard Deviation 1.9
|
4 days
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 30 daysPerformance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= "Non-oral feeding (tube fed)" and 100 = "Full diet (no restrictions)"
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
PSS Normalcy of Diet
|
51.7 units on a scale
Standard Deviation 24.4
|
36.7 units on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 3 daysOutcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Opioid Use
|
137.1 mg of oxycodone equivalent
Standard Deviation 115.2
|
147.3 mg of oxycodone equivalent
Standard Deviation 90.4
|
SECONDARY outcome
Timeframe: 21 daysThe University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= "Not at all" and 5="Extremely". The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively.
Outcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
UM-QOL Eating
|
59.3 units on a scale
Standard Deviation 19.5
|
60.1 units on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Arm I (Treatment)
n=35 Participants
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 Participants
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Days With Feeding Tube
|
4 days
Interval 2.0 to 311.0
|
11 days
Interval 2.0 to 298.0
|
Adverse Events
Arm I (Treatment)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Control)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Treatment)
n=35 participants at risk
Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Dexamethasone: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
Arm II (Control)
n=33 participants at risk
Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Dexamethasone: Given IV
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Transoral Robotic Surgery: Undergo TORS
|
|---|---|---|
|
Surgical and medical procedures
oropharyngeal hemorrhage
|
11.4%
4/35
|
9.1%
3/33 • Number of events 3
|
|
Surgical and medical procedures
Neck hematoma
|
5.7%
2/35
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/35
|
9.1%
3/33
|
|
Surgical and medical procedures
Chyle leak
|
2.9%
1/35
|
0.00%
0/33
|
|
Surgical and medical procedures
Readmission/failure to thrive
|
5.7%
2/35
|
0.00%
0/33
|
|
Surgical and medical procedures
abscess
|
2.9%
1/35
|
0.00%
0/33
|
Other adverse events
Adverse event data not reported
Additional Information
Daniel Clayburgh, MD PhD
Oregon Health and Science University
Phone: 503-494-8510
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place