Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

University of Vermont

Status and phase: Unknown; Phase 2

Conditions: Pegfilgrastim-induced Back and Leg Pain

Treatments: Drug: placebo; Drug: Loratadine

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01311336

VCC 1012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Loratadine

Active Comparator group

Description:

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

Treatment:

Drug: Loratadine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo