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Brief Title: Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies
Official Title: Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
Study ID: NCT02305979
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
Name: LeAnne Kennedy, PharmD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR