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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-04-30

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.

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Detailed Description

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Conditions

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Oropharyngeal Cancer Squamous Cell Carcinoma to the Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Lyrica at 300 mg per day

Group Type EXPERIMENTAL

Lyrica 300 mg

Intervention Type DRUG

Lyrica 300 mg per day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Lyrica 300 mg

Lyrica 300 mg per day

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No