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.



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/2/2017
Start Date:May 2014
Contact:Erin McMenamin, MSN, CRNP
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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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.


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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