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Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

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ClinicalTrials.gov Identifier: NCT01311336
Recruitment Status : Unknown
Verified January 2013 by Steven Grunberg, University of Vermont.
Recruitment status was:  Recruiting
First Posted : March 9, 2011
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pegfilgrastim-induced Back and Leg Pain Drug: Loratadine Drug: placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
Study Start Date : May 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT01311336


Contacts
Contact: Steven M Grunberg, MD 802-656-5457 steven.grunberg@uvm.edu
Contact: Karen M Wilson, MEd 802-656-4101 karen.m.wilson@uvm.edu

Locations
United States, Maine
Cancer Care of Maine Recruiting
Brewer, Maine, United States, 04412
Contact: Thomas H Openshaw, MD    207-973-7478    topenshaw@emh.org   
Principal Investigator: Thomas H Openshaw, MD         
Sub-Investigator: Andrew Hertler, MD         
Maine Center for Cancer Medicine Recruiting
Scarborough, Maine, United States, 04074
Contact: Matthew Dugan, DO    207-885-7600    duganm@mccm.org   
Principal Investigator: Matthew Dugan, DO         
Sub-Investigator: Tracey Weisberg, MD         
Sub-Investigator: Christian Thomas, MD         
York Hospital Recruiting
York, Maine, United States, 03909
Contact: Jonathan Eneman, MD    207-351-3777    jeneman@yorkhospital.com   
Principal Investigator: Jonathan Eneman, MD         
United States, New York
CR Wood Cancer Center Recruiting
Glens Falls, New York, United States, 12801
Contact: Aqeel Gillani, MD    518-926-6700    aqeelgillani@hotmail.com   
Principal Investigator: Aqeel Gillani, MD         
United States, Vermont
Mountainview Medical Center Recruiting
Berlin, Vermont, United States, 05602
Contact: John Valentine, MD    802-225-5400    john.valentine@cvmc.org   
Principal Investigator: John Valentine, MD         
Sub-Investigator: David Ospina, MD         
Vermont Cancer Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Steven M Grunberg, MD    802-656-5457    steven.grunberg@uvm.edu   
Contact: Karen M Wilson, MEd    802-656-4101    karen.m.wilson@uvm.edu   
Principal Investigator: Steven M Grunberg, MD         
Sub-Investigator: Joanna Schwartz, PharmD         
Vermont Center for Cancer Medicine Recruiting
Colchester, Vermont, United States, 05446
Contact: Dennis Sanders, MD    802-655-3400    Dennis.Sanders@vtmednet.org   
Sub-Investigator: Paul Unger, MD         
Sub-Investigator: Dennis Sanders, MD         
Sub-Investigator: Johannes Nunnink, MD         
Sponsors and Collaborators
University of Vermont
Cancer and Leukemia Group B
Investigators
Study Chair: Steven M Grunberg, MD University of Vermont
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Grunberg, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01311336     History of Changes
Other Study ID Numbers: VCC 1012
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Steven Grunberg, University of Vermont:
Pegfilgrastim
Loratadine
Myalgia/arthralgia

Additional relevant MeSH terms:
Lenograstim
Loratadine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action