A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.

Study Overview
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Brief Summary
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To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania.

Official Title
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A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.

Conditions
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Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck

Intervention / Treatment
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* Drug: Lyrica 300 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania Age at least 18 years old Treatment entails significant risk for symptomatic mucositis likely to require opioid analgesia, as per the discretion of treating physician/NP Subjects are capable of giving informed consent Exclusion Criteria: Patients anticipated to receive radiation therapy with Protons History of hypersensitivity to pregabalin or gabapentin History of seizure or currently taking anti-epileptic medication Creatinine clearance of less than 30 mL/min by Cockcroft-Gault estimate Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin History of serious mood disorder or attempted suicide as determined by patients history and physical and by using theDepression Screening Subjects with a score of greater than 10 or those answering #5 with scores greater than a 0 will be deemed ineligible to be enrolled on study History of angioedema New York Heart Association class III or IV heart failure Platelets of less than 150 mg/dL or history of thrombocytopenia The patient has any uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that would limit compliance or interfere with their ability to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lyrica at 300 mg per day<br> | Drug: Lyrica 300 mg<br>* Lyrica 300 mg per day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average/Cumulative Opioid Dose |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, radiation therapy