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

OHSU Knight Cancer Institute

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01748942

NCI-2012-02780 (Registry Identifier)

CR00021919

CPC-12095-L

IRB00008071 (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Arm I (treatment)

Experimental group

Description:

Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.

Treatment:

Drug: Dexamethasone

Procedure: Quality-of-Life Assessment

Procedure: Transoral Robotic Surgery

Other: Questionnaire Administration

Drug: Dexamethasone

Arm II (control)

Active Comparator group

Description:

Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.

Treatment:

Other: Placebo

Drug: Dexamethasone

Procedure: Quality-of-Life Assessment

Procedure: Transoral Robotic Surgery

Other: Questionnaire Administration

Drug: Dexamethasone