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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02305979

Enrollment

Registered

2014-12-03

Start date

2014-12-31

Completion date

2017-09-30

Last updated

2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

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).

Interventions

DRUGLoratadine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of bone pain following G-CSF administration	Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026