This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.
PRIMARY OBJECTIVES: I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for the management of postoperative pain and dysphagia following transoral robotic surgery (TORS) is superior to the current standard of a single injection of dexamethasone 10 mg. SECONDARY OBJECTIVES: I. Determine the effect of postoperative corticosteroids on postoperative dysphagia following TORS. II. Determine the effect of postoperative corticosteroids on length of hospital stay following TORS. III. Determine the complications associated with postoperative corticosteroid use after TORS. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone intravenously (IV) at the time of surgery and orally (PO) every 8 hours for up to 4 days following surgery. ARM II: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery. After completion of study treatment, patients are followed up for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
76
OHSU Knight Cancer Institute
Portland, Oregon, United States
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
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
Complications Associated With Postoperative Corticosteroid Use After TORS
A descriptive statistical analysis will be conducted on complications.
Time frame: Up to 30 days
Eating Assessment Tool (EAT)-10 Scores
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
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
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
PSS Normalcy of Diet
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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Ancillary studies
Ancillary studies
Undergo TORS
Time frame: 30 days
Opioid Use
Time frame: 3 days
UM-QOL Eating
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
Days With Feeding Tube
Time frame: 12 months