Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

NCT01311336 | Unknown Phase 2 DMC

• 1 other identifier: VCC 1012
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

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.

Conditions

Pegfilgrastim-induced Back and Leg Pain

Keywords

Pegfilgrastim; Loratadine; Myalgia/arthralgia

Outcome Measures

Primary Outcomes (1)

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

  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

  one week after pegfilgrastim

Secondary Outcomes (2)

• Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain

  one week after pegfilgrastim

• Incidence of pegfilgrastim-induced back and leg pain

  One week after pegfilgrastim

Study Arms (2)

Loratadine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Loratadine DRUG

loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

Also known as: Claritin

Loratadine

placebo DRUG

placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Cancer and Leukemia Group B: collaborator

Study Sites (7)

Cancer Care of Maine

Brewer, Maine, 04412, United States

RECRUITING

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

RECRUITING

York Hospital

York Village, Maine, 03909, United States

RECRUITING

CR Wood Cancer Center

Glens Falls, New York, 12801, United States

RECRUITING

Mountainview Medical Center

Berlin Corners, Vermont, 05602, United States

RECRUITING

Vermont Cancer Center

Burlington, Vermont, 05405, United States

RECRUITING

Vermont Center for Cancer Medicine

Colchester, Vermont, 05446, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26894485 DERIVED

MeSH Terms

Conditions

Myalgia; Arthralgia

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Steven M Grunberg, MD

  University of Vermont

  STUDY CHAIR

Central Study Contacts

Steven M Grunberg, MD

CONTACT

802-656-5457; steven.grunberg@uvm.edu

Karen M Wilson, MEd

CONTACT

802-656-4101; karen.m.wilson@uvm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 9, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (7)