Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pegfilgrastim-induced Back and Leg Pain

Intervention / Treatment
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* Drug: Loratadine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loratadine<br>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 | Drug: Loratadine<br>* loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim<br>* Other names: Claritin;|
| Placebo Comparator: Placebo<br>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 | Drug: placebo<br>* placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine | 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 | one week after pegfilgrastim | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain | Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain | one week after pegfilgrastim | 
| Incidence of pegfilgrastim-induced back and leg pain | Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain | One week after pegfilgrastim | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pegfilgrastim, Loratadine, Myalgia/arthralgia