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Trial record 11 of 65 for:    dry mouth | NIH

Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT01748942
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : September 12, 2017
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniel Clayburgh, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Dysphagia
Pain
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Interventions Drug: Dexamethasone
Other: Placebo
Procedure: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Transoral Robotic Surgery
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 39 37
Completed 35 33
Not Completed 4 4
Arm/Group Title Arm I (Treatment) Arm II (Control) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 35 33 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  91.4%
28
  84.8%
60
  88.2%
>=65 years
3
   8.6%
5
  15.2%
8
  11.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 68 participants
56
(44 to 72)
60
(44 to 75)
58
(44 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
Female
3
   8.6%
4
  12.1%
7
  10.3%
Male
32
  91.4%
29
  87.9%
61
  89.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 33 participants 68 participants
35 33 68
VAS pain score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 33 participants 68 participants
1.1  (1.8) 0.6  (1.3) 0.9  (1.6)
[1]
Measure Description: 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".
Tumor stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 68 participants
T1
21
  60.0%
15
  45.5%
36
  52.9%
T2
14
  40.0%
18
  54.5%
32
  47.1%
[1]
Measure Description:

Tumor stage is assessed using American Joint Committee on Cancer (AJCC) TNM staging of oropharyngeal squamous cell carcinoma:

T1 = Tumor 2 cm or less in greatest dimension. T2 = Tumor more than 2 cm but not more than 4 cm in greatest dimension. T3 = Tumor more than 4 cm in greatest dimension or extension to lingual surface of epiglottis.

T4a = Moderately advanced local disease. T4b = Very advance local disease.

EAT-10 score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 33 participants 68 participants
5.9  (7.6) 3.5  (6.2) 4.6  (6.9)
[1]
Measure Description: Mean overall score of the EAT-10 tool. 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".
PSS normalcy of diet   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 33 participants 68 participants
92.3  (16.4) 94.2  (15.0) 93.8  (15.4)
[1]
Measure Description: Performance 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)"
UM-QOL eating score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 33 participants 68 participants
89.6  (17.8) 93.75  (12.7) 89.6  (17.8)
[1]
Measure Description: The 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".
1.Primary Outcome
Title Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Hide Description 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.
Time Frame 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postoperative day #1 7.4  (2.0) 6.8  (2.3)
Postoperative day #2 6.0  (2.0) 6.4  (2.1)
Postoperative day #3 5.3  (2.0) 6.7  (1.9)
Postoperative day #7-21 3.0  (1.8) 2.5  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Complications Associated With Postoperative Corticosteroid Use After TORS
Hide Description A descriptive statistical analysis will be conducted on complications.
Time Frame Up to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Measure Type: Count of Participants
Unit of Measure: Participants
complication present
10
  28.6%
7
  21.2%
no complication
25
  71.4%
26
  78.8%
3.Secondary Outcome
Title Eating Assessment Tool (EAT)-10 Scores
Hide Description Statistical 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.
Time Frame Up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.0  (8.3) 20.2  (10.7)
4.Secondary Outcome
Title Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
Hide Description Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.
Time Frame Up to 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Median (Standard Deviation)
Unit of Measure: days
5  (1.9) 4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title PSS Normalcy of Diet
Hide Description Performance 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)"
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
51.7  (24.4) 36.7  (23.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Opioid Use
Hide Description [Not Specified]
Time Frame 3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: mg of oxycodone equivalent
137.1  (115.2) 147.3  (90.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title UM-QOL Eating
Hide Description The 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.
Time Frame 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.3  (19.5) 60.1  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Days With Feeding Tube
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 35 33
Median (Full Range)
Unit of Measure: days
4
(2 to 311)
11
(2 to 298)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Treatment), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Treatment) Arm II (Control)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (Treatment) Arm II (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Treatment) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/35 (28.57%)      7/33 (21.21%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia  0/35 (0.00%)  3/33 (9.09%) 
Surgical and medical procedures     
oropharyngeal hemorrhage   4/35 (11.43%)  3/33 (9.09%)  3
Neck hematoma  2/35 (5.71%)  1/33 (3.03%) 
Chyle leak  1/35 (2.86%)  0/33 (0.00%) 
Readmission/failure to thrive  2/35 (5.71%)  0/33 (0.00%) 
abscess  1/35 (2.86%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Treatment) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/33 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daniel Clayburgh, MD PhD
Organization: Oregon Health and Science University
Phone: 503-494-8510
Responsible Party: Daniel Clayburgh, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01748942     History of Changes
Other Study ID Numbers: IRB00008071
NCI-2012-02780 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CPC-12095-L
CR00021919
IRB00008071 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2012
First Posted: December 13, 2012
Results First Submitted: May 8, 2017
Results First Posted: September 12, 2017
Last Update Posted: June 19, 2018