Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Phase 2

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Loratadine	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine	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

Name	Time	Method
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain	one week after pegfilgrastim	Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain
Incidence of pegfilgrastim-induced back and leg pain	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

Locations (7): York Hospital
🇺🇸
York, Maine, United States
Mountainview Medical Center
🇺🇸
Berlin, Vermont, United States
Cancer Care of Maine
🇺🇸
Brewer, Maine, United States
CR Wood Cancer Center
🇺🇸
Glens Falls, New York, United States
Vermont Center for Cancer Medicine
🇺🇸
Colchester, Vermont, United States
Maine Center for Cancer Medicine
🇺🇸
Scarborough, Maine, United States
Vermont Cancer Center
🇺🇸
Burlington, Vermont, United States