Pregabalin (Lyrica) in the Management of Oral Mucositis Pain in Head/Neck Chemoradiation Therapy Patients

Brief Description Of Study

Double-blind, randomized, single-center pilot study to assess the effectiveness of pregabalin (Lyrica) in the management of mucositis pain in head and neck cancer.

Clinical Study Identifier: TX1044

Detailed Study Description

The purpose of this study is to investigate the use of a prescription drug called pregabalin (trade name Lyrica) in patients with head and neck cancer receiving chemoradiation therapy to see if pregabalin will 1.) help reduce the severity of pain caused by mucositis in head and neck cancer and 2.) to see if using pregabalin can reduce the amount of opioid pain medication that patients need for mucositis while receiving chemoradiation treatment. Mucositis is a word used to describe inflammation and ulceration in the treatment area. Mucositis is a temporary result of damage to the cells lining the mouth and throat by radiation and/or chemotherapy. Pregabalin is currently FDA-approved in the treatment of neuropathic pain for illnesses like Fibromyalgia and Diabetic Neuropathy. Neuropathic pain is a type of pain that occurs when nerve fibers are damaged or not working properly.

Additional Information About The Study

Study participants will take the investigational drug (pregabalin) or placebo (sugar pill) daily and complete weekly study questionnaires for the duration of their chemoradiation treatment and for another month after they complete chemoradiation. Total time in the study is approximately 3-4 months.

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To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: Pregabalin (Lyrica) in the Management of Oral Mucositis Pain in Head/Neck Chemoradiation Therapy Patients
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