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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pegfilgrastim-induced Back and Leg Pain

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine

Outcome Description:

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

Outcome Time Frame:

one week after pegfilgrastim

Safety Issue:

No

Principal Investigator

Steven M Grunberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Institutional Review Board

Study ID:

VCC 1012

NCT ID:

NCT01311336

Start Date:

May 2011

Completion Date:

June 2013

Related Keywords:

  • Pegfilgrastim-induced Back and Leg Pain
  • Pegfilgrastim
  • Loratadine
  • Myalgia/arthralgia

Name

Location

Vermont Cancer CenterBurlington, Vermont  05401-3498
CR Wood Cancer CenterGlen Falls, New York  12801
Cancer Care of MaineBangor, Maine  04401
Maine Center for Cancer MedicineScarborough, Maine  04074
York HospitalYork, Maine  03909
Mountainview Medical CenterBerlin, Vermont  05602
Vermont Center for Cancer MedicineColchester, Vermont  05446