Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
This study is currently recruiting participants.
Verified January 2013 by University of Vermont
Sponsor:
University of Vermont
Collaborator:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Steven Grunberg, University of Vermont
ClinicalTrials.gov Identifier:
NCT01311336
First received: March 8, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pegfilgrastim-induced Back and Leg Pain |
Drug: Loratadine Drug: placebo |
Phase 2 |
| Study Type: | 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 |
| Official Title: | Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim |
Resource links provided by NLM:
Further study details as provided by University of Vermont:
Primary Outcome Measures:
- Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine [ Time Frame: one week after pegfilgrastim ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain [ Time Frame: one week after pegfilgrastim ] [ Designated as safety issue: Yes ]Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain
- Incidence of pegfilgrastim-induced back and leg pain [ Time Frame: One week after pegfilgrastim ] [ Designated as safety issue: No ]Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain
| Estimated Enrollment: | 55 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Drug: Loratadine
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Other Name: Claritin
|
|
Placebo Comparator: 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
|
Drug: placebo
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Other Name: placebo
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311336
Contacts
| Contact: Steven M Grunberg, MD | 802-656-5457 | steven.grunberg@uvm.edu |
| Contact: Karen M Wilson, MEd | 802-656-4101 | karen.m.wilson@uvm.edu |
Locations
| United States, Maine | |
| Cancer Care of Maine | Recruiting |
| Brewer, Maine, United States, 04412 | |
| Contact: Thomas H Openshaw, MD 207-973-7478 topenshaw@emh.org | |
| Principal Investigator: Thomas H Openshaw, MD | |
| Sub-Investigator: Andrew Hertler, MD | |
| Maine Center for Cancer Medicine | Recruiting |
| Scarborough, Maine, United States, 04074 | |
| Contact: Matthew Dugan, DO 207-885-7600 duganm@mccm.org | |
| Principal Investigator: Matthew Dugan, DO | |
| Sub-Investigator: Tracey Weisberg, MD | |
| Sub-Investigator: Christian Thomas, MD | |
| York Hospital | Recruiting |
| York, Maine, United States, 03909 | |
| Contact: Jonathan Eneman, MD 207-351-3777 jeneman@yorkhospital.com | |
| Principal Investigator: Jonathan Eneman, MD | |
| United States, New York | |
| CR Wood Cancer Center | Recruiting |
| Glens Falls, New York, United States, 12801 | |
| Contact: Aqeel Gillani, MD 518-926-6700 aqeelgillani@hotmail.com | |
| Principal Investigator: Aqeel Gillani, MD | |
| United States, Vermont | |
| Mountainview Medical Center | Recruiting |
| Berlin, Vermont, United States, 05602 | |
| Contact: John Valentine, MD 802-225-5400 john.valentine@cvmc.org | |
| Principal Investigator: John Valentine, MD | |
| Sub-Investigator: David Ospina, MD | |
| Vermont Cancer Center | Recruiting |
| Burlington, Vermont, United States, 05405 | |
| Contact: Steven M Grunberg, MD 802-656-5457 steven.grunberg@uvm.edu | |
| Contact: Karen M Wilson, MEd 802-656-4101 karen.m.wilson@uvm.edu | |
| Principal Investigator: Steven M Grunberg, MD | |
| Sub-Investigator: Joanna Schwartz, PharmD | |
| Vermont Center for Cancer Medicine | Recruiting |
| Colchester, Vermont, United States, 05446 | |
| Contact: Dennis Sanders, MD 802-655-3400 Dennis.Sanders@vtmednet.org | |
| Sub-Investigator: Paul Unger, MD | |
| Sub-Investigator: Dennis Sanders, MD | |
| Sub-Investigator: Johannes Nunnink, MD | |
Sponsors and Collaborators
University of Vermont
Cancer and Leukemia Group B
Investigators
| Study Chair: | Steven M Grunberg, MD | University of Vermont |
More Information
No publications provided
| Responsible Party: | Steven Grunberg, Professor of Medicine, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01311336 History of Changes |
| Other Study ID Numbers: | VCC 1012 |
| Study First Received: | March 8, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Vermont:
|
Pegfilgrastim Loratadine Myalgia/arthralgia |
Additional relevant MeSH terms:
|
Loratadine Lenograstim Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 21, 2013