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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277548
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Squamous Cell Carcinoma to the Head and Neck Drug: Lyrica 300 mg Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lyrica at 300 mg per day Drug: Lyrica 300 mg
Lyrica 300 mg per day
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Average/Cumulative Opioid Dose [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277548


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Erin McMenamin, MSN, CRNP Abramson Cancer Center of the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Abramson Cancer Center of the University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] April 21, 2016

More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02277548    
Other Study ID Numbers: UPCC 43313
First Posted: October 29, 2014    Key Record Dates
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019
Last Verified: November 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
chemotherapy
radiation therapy
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Mucositis
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Otorhinolaryngologic Diseases
 Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs