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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Leukemia Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment with Loratadine

Loratadine

Intervention Type DRUG

Interventions

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Loratadine

Intervention Type DRUG

Other Intervention Names

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Claritin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No