Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Sponsor

University of Vermont (Other)

Overall Status

Unknown status

CT.gov ID

NCT01311336

Collaborator

Cancer and Leukemia Group B (Other)

Enrollment

Locations

Arms

Duration (Months)

7.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pegfilgrastim-induced Back and Leg Pain	Drug: Loratadine Drug: placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine [one week after pegfilgrastim]
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 [one week after pegfilgrastim]
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 [One week after pegfilgrastim]
Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Care of Maine	Brewer	Maine	United States	04412
2	Maine Center for Cancer Medicine	Scarborough	Maine	United States	04074
3	York Hospital	York	Maine	United States	03909
4	CR Wood Cancer Center	Glens Falls	New York	United States	12801
5	Mountainview Medical Center	Berlin	Vermont	United States	05602
6	Vermont Cancer Center	Burlington	Vermont	United States	05405
7	Vermont Center for Cancer Medicine	Colchester	Vermont	United States	05446

Sponsors and Collaborators

University of Vermont
Cancer and Leukemia Group B

Investigators

Study Chair: Steven M Grunberg, MD, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven Grunberg, Professor of Medicine, University of Vermont

ClinicalTrials.gov Identifier:

NCT01311336

Other Study ID Numbers:

VCC 1012

First Posted:

Mar 9, 2011

Last Update Posted:

Jan 24, 2013

Last Verified:

Jan 1, 2013

Keywords provided by Steven Grunberg, Professor of Medicine, University of Vermont

Pegfilgrastim

Loratadine

Myalgia/arthralgia

Additional relevant MeSH terms:

Loratadine

Study Results

No Results Posted as of Jan 24, 2013