Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

January 23, 2013 updated by: Steven Grunberg, University of Vermont

Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim

The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pegfilgrastim is a myeloid growth factor that stimulates neutrophil precursors and can be used to decrease infection risk associated with neutropenia. However pegfilgrastim may induce back and leg pain in 20-50% of patients. No intervention has been consistently successful in treating or preventing this pain.

The exact mechanism of pegfilgrastim-induced pain is unknown but may be related to histamine-mediated inflammation. Several case reports and anecdotal reports have suggested efficacy of antihistamines for this indication.

This study will have two parts. In the first part (Observational Phase), patients receiving pegfilgrastim will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain. In the second part (Treatment Phase), patients who previously experienced such pain will be randomized to receive a 7-day course of either the antihistamine loratadine or placebo to determine whether pegfilgrastim-induced back and leg pain can be prevented with this intervention.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maine
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Cancer Care of Maine
        • Contact:
        • Principal Investigator:
          • Thomas H Openshaw, MD
        • Sub-Investigator:
          • Andrew Hertler, MD
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Center for Cancer Medicine
        • Contact:
        • Principal Investigator:
          • Matthew Dugan, DO
        • Sub-Investigator:
          • Tracey Weisberg, MD
        • Sub-Investigator:
          • Christian Thomas, MD
      • York, Maine, United States, 03909
        • Recruiting
        • York Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan Eneman, MD
    • New York
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • CR Wood Cancer Center
        • Contact:
        • Principal Investigator:
          • Aqeel Gillani, MD
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Mountainview Medical Center
        • Contact:
        • Principal Investigator:
          • John Valentine, MD
        • Sub-Investigator:
          • David Ospina, MD
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • Vermont Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven M Grunberg, MD
        • Sub-Investigator:
          • Joanna Schwartz, PharmD
      • Colchester, Vermont, United States, 05446
        • Recruiting
        • Vermont Center for Cancer Medicine
        • Contact:
        • Sub-Investigator:
          • Paul Unger, MD
        • Sub-Investigator:
          • Dennis Sanders, MD
        • Sub-Investigator:
          • Johannes Nunnink, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologic or cytologic evidence of malignancy
  • scheduled to receive pegfilgrastim with two consecutive cycles of similar chemotherapy with at least a 14 day interval between cycles
  • adequate renal function: estimated creatinine clearance > 30 ml/min
  • adequate hepatic function: AST, ALT, total bilirubin <= 2.5 x ULN
  • age >= 18 years
  • performance status 0-3
  • able to read and understand English
  • signed Informed Consent

Exclusion Criteria:

  • history of hypersensitivity or intolerance to antihistamines
  • concurrent use of antihistamines other than study medications during or for 2 days prior to the study period except for a single dose of antihistamine as required for administration of chemotherapy or blood transfusion
  • concomitant use of amiodarone
  • previous use of pegfilgrastim or filgrastim

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Loratadine
Loratadine 10 mg once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle
Drug: Loratadine
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Other Names:
  • Claritin
Placebo Comparator: Placebo
Placebo once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle
Drug: placebo
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Time Frame: one week after pegfilgrastim
Patients who experience significant pegfilgrastim-induced back and leg pain during the first cycle of pegfilgrastim therapy are randomized to receive loratadine or placebo during the second cycle of pegfilgrastim therapy
one week after pegfilgrastim

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
Time Frame: one week after pegfilgrastim
Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain
one week after pegfilgrastim
Incidence of pegfilgrastim-induced back and leg pain
Time Frame: One week after pegfilgrastim
Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain
One week after pegfilgrastim

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Cancer and Leukemia Group B

Investigators

  • Study Chair: Steven M Grunberg, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCC 1012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pegfilgrastim-induced Back and Leg Pain

Clinical Trials on Loratadine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe