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Pegfilgrastim-induced Back and Leg Pain | Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Pegfilgrastim-induced Back and Leg Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pegfilgrastim-induced Back and Leg Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Loratadineloratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

Drug:placeboplacebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

LoratadineLoratadine 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

PlaceboPlacebo 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

Study Status

Unknown status

Start Date: May 2011

Completed Date: June 2013

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine

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

Study sponsors, principal investigator, and references

Principal Investigator: Steven M Grunberg, MD

Lead Sponsor: University of Vermont

Collaborator: Cancer and Leukemia Group B

More information:https://clinicaltrials.gov/show/NCT01311336

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