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

NCT02305979 | Completed

• 2 other identifiers: IRB00030701CCCWFU 98414
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of bone pain following G-CSF administration

  Day 1

Study Arms (1)

Treatment with Loratadine

Treatment with Loratadine

Drug: Loratadine

Interventions

Loratadine DRUG

Also known as: Claritin

Treatment with Loratadine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Wake Forest Baptist Health Hematology and Oncology Clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• LeAnne Kennedy, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)