Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University of Vermont
- Enrollment
- 55
- Locations
- 7
- Primary Endpoint
- Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Loratadine (Drug)
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
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Time Frame: 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 Outcomes
- Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain(one week after pegfilgrastim)
- Incidence of pegfilgrastim-induced back and leg pain(One week after pegfilgrastim)
Investigators
Steven Grunberg
Professor of Medicine
University of Vermont