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.

Not Applicable

Completed

• Conditions: Oropharyngeal Cancer; Squamous Cell Carcinoma to the Head and Neck
• Interventions: Drug: Lyrica 300 mg; Drug: Placebo

• Registration Number: NCT02277548
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Results First Submitted: 2019-10-07
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-04
• Last Update Submitted: 2019-11-04
• Results First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyrica at 300 mg per day	Lyrica 300 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Average/Cumulative Opioid Dose	18 months

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States