Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
研究概览
简要总结
No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Eligible patients were 18 years or older.
- •Confirmed diagnosis of breast cancer.
- •Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles.
- •Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
排除标准
- •Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
- •Patients receiving famotidine in the previous 72 hours.
- •Patient receiving any antihistaminic in the previous 72 hours.
- •Hypersensitivity to famotidine or loratadine.
- •Patient receiving opioid or adjuvant analgesic.
研究组 & 干预措施
Intervention
(intervention group) patients who will receive filgrastim plus oral famotidine 20 mg once daily and loratadine 10 mg once daily for the full filgrastim treatment period.
干预措施: famotidine and loratadine (Drug)
Control
(control group) patients who will receive placebo plus filgrastim.
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
时间窗: two weeks
Difference between the two arms regarding the incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
次要结局
未报告次要终点
研究者
Noha Mansour
Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department
Mansoura University