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.

NCT02277548 | Completed Results DMC

• 1 other identifier: UPCC 43313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancer; Squamous Cell Carcinoma to the Head and Neck

Keywords

chemotherapy; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Average/Cumulative Opioid Dose

  18 months

Study Arms (2)

Lyrica at 300 mg per day

EXPERIMENTAL

Drug: Lyrica 300 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lyrica 300 mg DRUG

Lyrica 300 mg per day

Lyrica at 300 mg per day

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Erin McMenamin
• Organization: University of Pennsylvania

Erin.McMenamin@pennmedicine.upenn.edu

251-662-2428

Study Officials

• Erin McMenamin, MSN, CRNP

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-11

Locations

US (1)