Pegfilgrastim-induced Back and Leg Pain
Conditions
Keywords
Pegfilgrastim, Loratadine, Myalgia/arthralgia
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.
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.
Interventions
DRUGLoratadine
loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
DRUGplacebo
placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
Sponsors
Cancer and Leukemia Group B
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactSteven M Grunberg, MD
Backup ContactKaren M Wilson, MEd
Outcome results
None listed