Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Launched by UNIVERSITY OF VERMONT · Mar 8, 2011

Keywords

ClinConnect Summary

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 (Observation...

Gender

ALL

Eligibility 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