Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Pegfilgrastim-induced Back and Leg Pain

In brief

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.

Key facts

Study ID

NCT01311336

Run by

University of Vermont

People needed

55

Starts

2011-05-01

Expected to finish

2013-06-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cancer Care of Maine — Brewer, Maine, United States (enrolling)
• Maine Center for Cancer Medicine — Scarborough, Maine, United States (enrolling)
• York Hospital — York Village, Maine, United States (enrolling)
• CR Wood Cancer Center — Glens Falls, New York, United States (enrolling)
• Mountainview Medical Center — Berlin Corners, Vermont, United States (enrolling)
• Vermont Cancer Center — Burlington, Vermont, United States (enrolling)
• Vermont Center for Cancer Medicine — Colchester, Vermont, United States (enrolling)

Full record on ClinicalTrials.gov

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