Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Collaborator: Cancer and Leukemia Group B
• Treatments: Lenograstim; Loratadine

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