Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305979
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Leukemia Lymphoma Drug: Loratadine

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
Actual Study Start Date : December 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Loratadine

Group/Cohort Intervention/treatment
Treatment with Loratadine
Treatment with Loratadine
Drug: Loratadine
Other Name: Claritin




Primary Outcome Measures :
  1. Incidence of bone pain following G-CSF administration [ Time Frame: Day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Wake Forest Baptist Health Hematology and Oncology Clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305979


Locations
Layout table for location information
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: LeAnne Kennedy, PharmD Wake Forest University Health Sciences
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02305979    
Other Study ID Numbers: IRB00030701
CCCWFU 98414 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs