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| Name | Class |
|---|---|
| Cancer and Leukemia Group B | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loratadine | Drug | loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain | Adverse events will be recorded for patients receiving loratadine or placebo to prevent pegfilgrastim-induced back and leg pain | one week after pegfilgrastim |
| Incidence of pegfilgrastim-induced back and leg pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Steven M Grunberg, MD | University of Vermont | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Care of Maine | Recruiting | Brewer | Maine | 04412 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26894485 | Derived | 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. |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| placebo | Drug | placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim |
|
Patients receiving pegfilgrastim for the first time will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain |
| One week after pegfilgrastim |
| Maine Center for Cancer Medicine | Recruiting | Scarborough | Maine | 04074 | United States |
|
| York Hospital | Recruiting | York Village | Maine | 03909 | United States |
|
| CR Wood Cancer Center | Recruiting | Glens Falls | New York | 12801 | United States |
|
| Mountainview Medical Center | Recruiting | Berlin Corners | Vermont | 05602 | United States |
|
| Vermont Cancer Center | Recruiting | Burlington | Vermont | 05405 | United States |
|
| Vermont Center for Cancer Medicine | Recruiting | Colchester | Vermont | 05446 | United States |
|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |