NCT01748942

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

A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia
• Pain
• Stage I Oropharyngeal Squamous Cell Carcinoma
• Stage II Oropharyngeal Squamous Cell Carcinoma
• Stage III Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given IV
DRUG	Dexamethasone	Given PO
OTHER	Placebo	Given PO
PROCEDURE	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Transoral Robotic Surgery	Undergo TORS

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-07-01
• Completion: 2017-03-29
• First posted: 2012-12-13
• Last updated: 2018-06-19
• Results posted: 2017-09-12

Locations

1 site across 1 country: United States