Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies



Status:Completed
Conditions:Blood Cancer, Lymphoma, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/5/2018
Start Date:December 2014
End Date:September 2017

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Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies

The purpose of this project is to assess the efficacy of loratadine in decreasing the
incidence and severity of bone pain following G-CSF administration in patients with
hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells,
and patients who have undergone an autologous hematopoietic cell transplant. This is a
different patient population than those being assessed in current clinical trials.

Objectives

The primary objective is to determine the incidence of bone pain following G-CSF
administration in patients with hematologic malignancies, patients undergoing mobilization of
hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic
cell transplant. Incidence will be determined via patient-reported incidence following G-CSF
administration.

Secondary objectives include determining the efficacy of loratadine for bone pain prevention
as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the
survey).

Inclusion Criteria:

- Receiving a G-CSF after the institution practice change

- Receiving a G-CSF for one of the following indications:

- Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma

- Mobilization of hematopoietic progenitor cells

- Neutropenia prevention following autologous hematopoietic cell transplant

- Took loratadine per protocol with G-CSF administration

- Completed a survey

Exclusion Criteria:

- Taking daily antihistamines for allergies, asthma, or other indications, not including
bone pain

- Taking daily NSAIDs, with the exception of aspirin, for chronic conditions

- Treatment for solid tumor cancers

- Receiving bone modifying agents for bone pain associated with metastatic disease or
other chronic conditions
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Phone: 336-713-3416
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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Winston-Salem, NC
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