Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Ca… (NCT01748942) | Clinical Trial Compass
CompletedNot Applicable
Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer
United States76 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 reco…
What they're measuring
1
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale