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

Completed

• Conditions: Leukemia; Lymphoma
• Interventions: Drug: Loratadine

• Registration Number: NCT02305979
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with Loratadine	Loratadine	Treatment with Loratadine

Primary Outcome Measures

Name	Time	Method
Incidence of bone pain following G-CSF administration	Day 1

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States