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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
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring chemotherapy, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 27, 2014
Last Updated
November 4, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
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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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