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

  • STATUS
    Recruiting
  • participants needed
    20
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Updated on 19 February 2024

Summary

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.

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.

FAQ

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.

Details
Condition Head and Neck Neoplasms, Oral cancer, Cancer
Age 18years - 100years
Clinical Study IdentifierTX1044
Last Modified on19 February 2024

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