Clinical trial NCT01311336: Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
Official title: Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pegfilgrastim-induced Back and Leg Pain
Keywords: Pegfilgrastim
Loratadine
Myalgia/arthralgia
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Cancer and Leukemia Group B
First posted: 2011-03-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
timeFrame: one week after pegfilgrastim
Secondary outcomes:
measure: Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
timeFrame: one week after pegfilgrastim
measure: Incidence of pegfilgrastim-induced back and leg pain
timeFrame: One week after pegfilgrastim
Other outcomes:
Locations:
city: Brewer
country: United States
facility: Cancer Care of Maine
state: Maine
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: York
country: United States
facility: York Hospital
state: Maine
city: Glens Falls
country: United States
facility: CR Wood Cancer Center
state: New York
city: Berlin
country: United States
facility: Mountainview Medical Center
state: Vermont
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
city: Colchester
country: United States
facility: Vermont Center for Cancer Medicine
state: Vermont
Study officials:
affiliation: University of Vermont
name: Steven M Grunberg, MD
role: STUDY_CHAIR
References:
citation: Moukharskaya J, Abrams DM, Ashikaga T, Khan F, Schwartz J, Wilson K, Verschraegen C, Openshaw T, Valentine J, Eneman J, Unger P, Ades S. Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Support Care Cancer. 2016 Jul;24(7):3085-93. doi: 10.1007/s00520-016-3119-0. Epub 2016 Feb 19.