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
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Study Type | Interventional |
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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) |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 33 participants | 68 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
32 91.4%
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28 84.8%
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60 88.2%
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>=65 years |
3 8.6%
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5 15.2%
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8 11.8%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 35 participants | 33 participants | 68 participants | |
56
(44 to 72)
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60
(44 to 75)
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58
(44 to 75)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 33 participants | 68 participants | |
Female |
3 8.6%
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4 12.1%
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7 10.3%
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Male |
32 91.4%
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29 87.9%
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61 89.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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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".
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Tumor stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 33 participants | 68 participants | |
T1 |
21 60.0%
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15 45.5%
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36 52.9%
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T2 |
14 40.0%
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18 54.5%
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32 47.1%
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[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. |
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EAT-10 score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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".
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PSS normalcy of diet
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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)"
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UM-QOL eating score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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".
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Name/Title: | Daniel Clayburgh, MD PhD |
Organization: | Oregon Health and Science University |
Phone: | 503-494-8510 |
EMail: | clayburg@ohsu.edu |
Responsible Party: | Daniel Clayburgh, OHSU Knight Cancer Institute |
ClinicalTrials.gov Identifier: | NCT01748942 |
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 |