Status:
COMPLETED
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.
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Oropharyngeal Cancer
Squamous Cell Carcinoma to the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02277548
Start Date
May 1 2014
End Date
April 1 2018
Last Update
November 21 2019
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104