NCT02277548CompletedNot Applicable
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.
Abramson Cancer Center at Penn Medicine1 site in 1 country20 target enrollmentStarted: May 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Average/Cumulative Opioid Dose
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lyrica at 300 mg per day
Experimental
Intervention: Lyrica 300 mg (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Average/Cumulative Opioid Dose
Time Frame: 18 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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