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

Wake Forest University (WFU)

Status: Completed

Conditions: Lymphoma; Leukemia

Treatments: Drug: Loratadine

Study type: Observational

Funder types: Other

Identifiers

NCT02305979

CCCWFU 98414 (Other Identifier)

IRB00030701

Details and patient eligibility

About

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.

Full 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).

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

61 participants in 1 patient group

Treatment with Loratadine

Description:

Treatment with Loratadine

Treatment:

Drug: Loratadine