Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Condition(s) targeted: Pegfilgrastim-induced Back and Leg Pain

Intervention: Loratadine (Drug); placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Vermont

Official(s) and/or principal investigator(s):
Steven M Grunberg, MD, Study Chair, Affiliation: University of Vermont

Overall contact:
Steven M Grunberg, MD, Phone: 802-656-5457, Email: steven.grunberg@uvm.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine

Secondary outcome:

Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain

Incidence of pegfilgrastim-induced back and leg pain

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Steven M Grunberg, MD, Phone: 802-656-5457, Email: steven.grunberg@uvm.edu

Cancer Care of Maine, Brewer, Maine 04412, United States; Recruiting
Thomas H Openshaw, MD, Phone: 207-973-7478, Email: topenshaw@emh.org
Thomas H Openshaw, MD, Principal Investigator
Andrew Hertler, MD, Sub-Investigator

Maine Center for Cancer Medicine, Scarborough, Maine 04074, United States; Recruiting
Matthew Dugan, DO, Phone: 207-885-7600, Email: duganm@mccm.org
Matthew Dugan, DO, Principal Investigator
Tracey Weisberg, MD, Sub-Investigator
Christian Thomas, MD, Sub-Investigator

York Hospital, York, Maine 03909, United States; Recruiting
Jonathan Eneman, MD, Phone: 207-351-3777, Email: jeneman@yorkhospital.com
Jonathan Eneman, MD, Principal Investigator

CR Wood Cancer Center, Glens Falls, New York 12801, United States; Recruiting
Aqeel Gillani, MD, Phone: 518-926-6700, Email: aqeelgillani@hotmail.com
Aqeel Gillani, MD, Principal Investigator

Mountainview Medical Center, Berlin, Vermont 05602, United States; Recruiting
John Valentine, MD, Phone: 802-225-5400, Email: john.valentine@cvmc.org
John Valentine, MD, Principal Investigator
David Ospina, MD, Sub-Investigator

Vermont Cancer Center, Burlington, Vermont 05405, United States; Recruiting
Steven M Grunberg, MD, Phone: 802-656-5457, Email: steven.grunberg@uvm.edu
Karen M Wilson, MEd, Phone: 802-656-4101, Email: karen.m.wilson@uvm.edu
Steven M Grunberg, MD, Principal Investigator
Joanna Schwartz, PharmD, Sub-Investigator

Vermont Center for Cancer Medicine, Colchester, Vermont 05446, United States; Recruiting
Dennis Sanders, MD, Phone: 802-655-3400, Email: Dennis.Sanders@vtmednet.org
Paul Unger, MD, Sub-Investigator
Dennis Sanders, MD, Sub-Investigator
Johannes Nunnink, MD, Sub-Investigator

Starting date: May 2011
Last updated: January 23, 2013