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Completed

NCT Number: NCT02305979

Evaluation of Loratadine for G-CSF 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loratadine

Drug

Other names: Claritin

Primary outcomes

  1. Incidence of bone pain following G-CSF administration

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.