Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
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
No
Steven M Grunberg, MD
Study Chair
University of Vermont
United States: Institutional Review Board
VCC 1012
NCT01311336
May 2011
June 2013
Name | Location |
---|---|
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CR Wood Cancer Center | Glen Falls, New York 12801 |
Cancer Care of Maine | Bangor, Maine 04401 |
Maine Center for Cancer Medicine | Scarborough, Maine 04074 |
York Hospital | York, Maine 03909 |
Mountainview Medical Center | Berlin, Vermont 05602 |
Vermont Center for Cancer Medicine | Colchester, Vermont 05446 |