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

Not Applicable

Completed

Conditions: Dysphagia
Pain
Stage I Oropharyngeal Squamous Cell Carcinoma
Stage II Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma

Interventions: Drug: Dexamethasone
Procedure: Quality-of-Life Assessment
Other: Placebo
Other: Questionnaire Administration
Procedure: Transoral Robotic Surgery

Registration Number: NCT01748942

Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

Inclusion Criteria

Patients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates
Macroscopic resection of the tumor via TORS must be planned with curative intent
Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients with known distant metastases or other malignancies
Patients with a history of allergy or adverse reaction to corticosteroids
Patients with a history of diabetes
Patients with fasting capillary blood glucose of > 140 on the day of surgery
Patients on chronic corticosteroids
Chronic alcohol abuse (> 6 alcoholic beverages daily)
Patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
Patients taking significant cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, Rifampin, efavirenz, nevirapine
Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap
Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
Psychiatric illness/social situations that would limit compliance with study requirements
Excluded patients will be allowed to participate in the trial on an observational basis only

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (treatment)	Dexamethasone	Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Arm I (treatment)	Quality-of-Life Assessment	Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Arm I (treatment)	Questionnaire Administration	Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Arm I (treatment)	Transoral Robotic Surgery	Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.
Arm II (control)	Placebo	Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Arm II (control)	Quality-of-Life Assessment	Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Arm II (control)	Questionnaire Administration	Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Arm II (control)	Transoral Robotic Surgery	Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Arm II (control)	Dexamethasone	Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.

Primary Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Eating Assessment Tool (EAT)-10 Scores	Up to 12 months	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.
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)	Up to 21 days	Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.
Complications Associated With Postoperative Corticosteroid Use After TORS	Up to 30 days	A descriptive statistical analysis will be conducted on complications.
PSS Normalcy of Diet	30 days	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)"
Opioid Use	3 days
UM-QOL Eating	21 days	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.
Days With Feeding Tube	12 months