Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
NCT ID: NCT01311336
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
55 participants
INTERVENTIONAL
2011-05-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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
Loratadine
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
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
placebo
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Interventions
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Loratadine
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
placebo
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cancer and Leukemia Group B
NETWORK
University of Vermont
OTHER
Responsible Party
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Steven Grunberg
Professor of Medicine
Principal Investigators
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Steven M Grunberg, MD
Role: STUDY_CHAIR
University of Vermont
Locations
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Cancer Care of Maine
Brewer, Maine, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
York Hospital
York Village, Maine, United States
CR Wood Cancer Center
Glens Falls, New York, United States
Mountainview Medical Center
Berlin Corners, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Vermont Center for Cancer Medicine
Colchester, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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VCC 1012
Identifier Type: -
Identifier Source: org_study_id
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