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OpenTrials
Completed

NCT Number: NCT02277548

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lyrica 300 mg

Drug

Lyrica 300 mg per day

Placebo

Drug

Primary outcomes

  1. Average/Cumulative Opioid Dose

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 29, 2014
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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