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Trial record 12 of 62 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 ]

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

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

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

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

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

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

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


  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