Pain Clinical Trial
Official title:
A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
Verified date | June 2018 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | March 29, 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 21 days | |
Secondary | Complications Associated With Postoperative Corticosteroid Use After TORS | A descriptive statistical analysis will be conducted on complications. | Up to 30 days | |
Secondary | 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. | Up to 12 months | |
Secondary | 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. | Up to 21 days | |
Secondary | 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)" | 30 days | |
Secondary | Opioid Use | 3 days | ||
Secondary | 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. | 21 days | |
Secondary | Days With Feeding Tube | 12 months |
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