IRB #

IRB00008071

Title

Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery

Principal Investigator

Neil Gross

Study Purpose

The purpose of this study is to determine whether post-operative steroid treatment can help manage pain in patients following transoral robotic surgery (TORS) for head and neck cancer.

Medical Condition(s)

Oropharyngeal squamous cell carinoma (SCC).

Eligibility Criteria

Adults 18 years of age or older with a diagnosis of oropharyngeal SCC. TORS must be planned as standard treatment for their cancer.

Patients with the following will not be eligible for participation: distant cancer metastases, history of allergy or adverse reaction to corticosteroids, history of diabetes, chronic alcohol abuse (more than 6 alcoholic beverages daily), history of severe chronic pain or on high dose narcotics (more than 25 mg oxycodone or equivalent daily).

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive either an oral dose of corticosteroid or placebo every 8 hours for the first fours days after surgery. One standard follow-up appointment will be held in clinic within 7 to 21 days after surgery.

Minors Included

No

Contact

Will Stott at stottw@ohsu.edu or (503) 418-9235

Sponsor

Investigator initiated with study drug provided by Astellas Pharma Global Development, Inc.

Recruitment End

01/05/2015

Compensation Provided

No