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.
Primary Purpose
Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lyrica 300 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring chemotherapy, radiation therapy
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lyrica at 300 mg per day
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Average/Cumulative Opioid Dose
Secondary Outcome Measures
Full Information
NCT ID
NCT02277548
First Posted
October 27, 2014
Last Updated
November 4, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02277548
Brief Title
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.
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck
Keywords
chemotherapy, radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lyrica at 300 mg per day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lyrica 300 mg
Intervention Description
Lyrica 300 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Average/Cumulative Opioid Dose
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin McMenamin, MSN, CRNP
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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.
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