Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Incidence of bone pain following G-CSF administration
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment with Loratadine
Treatment with Loratadine
干预措施: Loratadine (Drug)
结局指标
主要结局
Incidence of bone pain following G-CSF administration
时间窗: Day 1
次要结局
未报告次要终点