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Trial record 12 of 64 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm I (Treatment)   Arm II (Control)
STARTED   39   37 
COMPLETED   35   33 
NOT COMPLETED   4   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Arm I (Treatment)   Arm II (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   33   68 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 56 
 (44 to 72) 
 60 
 (44 to 75) 
 58 
 (44 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3   8.6%      4  12.1%      7  10.3% 
Male      32  91.4%      29  87.9%      61  89.7% 
Region of Enrollment 
[Units: Participants]
     
United States   35   33   68 
VAS pain score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.1  (1.8)   0.6  (1.3)   0.9  (1.6) 
[1] 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] 
[Units: Participants]
Count of Participants
     
T1      21  60.0%      15  45.5%      36  52.9% 
T2      14  40.0%      18  54.5%      32  47.1% 
[1]

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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.9  (7.6)   3.5  (6.2)   4.6  (6.9) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 92.3  (16.4)   94.2  (15.0)   93.8  (15.4) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 89.6  (17.8)   93.75  (12.7)   89.6  (17.8) 
[1] 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".


  Outcome Measures

1.  Primary:   Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale   [ Time Frame: 21 days ]

Measure Type Primary
Measure Title Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
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". 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale 
[Units: Units on a scale]
Mean (Standard Deviation)
   
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) 


Statistical Analysis 1 for Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.25
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Complications Associated With Postoperative Corticosteroid Use After TORS   [ Time Frame: Up to 30 days ]

Measure Type Secondary
Measure Title Complications Associated With Postoperative Corticosteroid Use After TORS
Measure Description A descriptive statistical analysis will be conducted on complications.
Time Frame Up to 30 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Complications Associated With Postoperative Corticosteroid Use After TORS 
[Units: Participants]
Count of Participants
   
complication present      10  28.6%      7  21.2% 
no complication      25  71.4%      26  78.8% 

No statistical analysis provided for Complications Associated With Postoperative Corticosteroid Use After TORS



3.  Secondary:   Eating Assessment Tool (EAT)-10 Scores   [ Time Frame: Up to 12 months ]

Measure Type Secondary
Measure Title Eating Assessment Tool (EAT)-10 Scores
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Eating Assessment Tool (EAT)-10 Scores 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.0  (8.3)   20.2  (10.7) 

No statistical analysis provided for Eating Assessment Tool (EAT)-10 Scores



4.  Secondary:   Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)   [ Time Frame: Up to 21 days ]

Measure Type Secondary
Measure Title Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge) 
[Units: Days]
Median (Standard Deviation)
 5  (1.9)   4  (1.2) 


Statistical Analysis 1 for Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Log Rank
P Value [4] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   PSS Normalcy of Diet   [ Time Frame: 30 days ]

Measure Type Secondary
Measure Title PSS Normalcy of Diet
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)"
Time Frame 30 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
PSS Normalcy of Diet 
[Units: Units on a scale]
Mean (Standard Deviation)
 51.7  (24.4)   36.7  (23.4) 


Statistical Analysis 1 for PSS Normalcy of Diet
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.009
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Opioid Use   [ Time Frame: 3 days ]

Measure Type Secondary
Measure Title Opioid Use
Measure Description No text entered.
Time Frame 3 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Opioid Use 
[Units: Mg of oxycodone equivalent]
Mean (Standard Deviation)
 137.1  (115.2)   147.3  (90.4) 


Statistical Analysis 1 for Opioid Use
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.33
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   UM-QOL Eating   [ Time Frame: 21 days ]

Measure Type Secondary
Measure Title UM-QOL Eating
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". 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
UM-QOL Eating 
[Units: Units on a scale]
Mean (Standard Deviation)
 59.3  (19.5)   60.1  (19.4) 


Statistical Analysis 1 for UM-QOL Eating
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.96
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Days With Feeding Tube   [ Time Frame: 12 months ]

Measure Type Secondary
Measure Title Days With Feeding Tube
Measure Description No text entered.
Time Frame 12 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Measured Values
   Arm I (Treatment)   Arm II (Control) 
Participants Analyzed   35   33 
Days With Feeding Tube 
[Units: Days]
Median (Full Range)
 4 
 (2 to 311) 
 11 
 (2 to 298) 


Statistical Analysis 1 for Days With Feeding Tube
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Log Rank
P Value [4] 0.15
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: clayburg@ohsu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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