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.

Oropharyngeal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277548
• Other study ID #: UPCC 43313
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma to the Head and Neck

Intervention

Drug:
• Lyrica 300 mg
Lyrica 300 mg per day
• Placebo

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average/Cumulative Opioid Dose		18 months