Recruiting
Phase 2

Loratadine with Pegfilgrastim

Sponsor:

University of Vermont

Code:

NCT01311336

Conditions

Pegfilgrastim-induced Back and Leg Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Loratadine

placebo

Study Details

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

Study ID

NCT01311336

Start date

May, 2011

Status verified date

Jan, 2013

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

Interventions

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

Primary outcome measure

  • Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine [ Time Frame: one week after pegfilgrastim ]

Central Contacts and Locations

Central contacts

Steven M Grunberg, MD

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

Karen M Wilson, MEd

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

Locations

Cancer Care of Maine

Recruiting

Brewer, Maine, United States, 04412

Contacts

Thomas H Openshaw, MD

207-973-7478topenshaw@emh.org

Principal Investigator:

Thomas H Openshaw, MD

Maine Center for Cancer Medicine

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Matthew Dugan, DO

207-885-7600duganm@mccm.org

Principal Investigator:

Matthew Dugan, DO

York Hospital

Recruiting

York, Maine, United States, 03909

Contacts

Jonathan Eneman, MD

207-351-3777jeneman@yorkhospital.com

Principal Investigator:

Jonathan Eneman, MD

CR Wood Cancer Center

Recruiting

Glens Falls, New York, United States, 12801

Contacts

Aqeel Gillani, MD

518-926-6700aqeelgillani@hotmail.com

Principal Investigator:

Aqeel Gillani, MD

Mountainview Medical Center

Recruiting

Berlin, Vermont, United States, 05602

Contacts

John Valentine, MD

802-225-5400john.valentine@cvmc.org

Principal Investigator:

John Valentine, MD

Vermont Cancer Center

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Steven M Grunberg, MD

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

Karen M Wilson, MEd

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

Principal Investigator:

Steven M Grunberg, MD

Vermont Center for Cancer Medicine

Recruiting

Colchester, Vermont, United States, 05446

Contacts

Dennis Sanders, MD

802-655-3400Dennis.Sanders@vtmednet.org

More Information

Sponsor

University of Vermont

Last update posted

Jan 24, 2013

Last verified

Jan, 2013

Keywords

  • Pegfilgrastim
  • Loratadine
  • Myalgia/arthralgia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2013-01-24.