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

Completed · Not applicable · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01748942

Run by

OHSU Knight Cancer Institute

People needed

76

Starts

2012-12-01

Expected to finish

2017-03-29

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.