Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Development of paclitaxel-induced peripheral neuropathy
研究概览
简要总结
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.
The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.
排除标准
- •Known hypersensitivity to Losartan.
- •Not Known Hypertensive patients
- •Not Known Diabetic patients
- •Treatment with Losartan/ARBs/ACE-I prior to the study.
- •Previous neuropathy
- •Renal impairment (Serum creatinine > 2 mg/dl)
- •Significant liver disease: liver enzymes 2 folds the upper normal limit
- •Metastatic breast cancer
- •Pregnancy or lactation
- •Taking other medication for neuropathic pain
- •Significant Hypotension
研究组 & 干预措施
Intervention arm
These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg
干预措施: Losartan (Drug)
结局指标
主要结局
Development of paclitaxel-induced peripheral neuropathy
时间窗: 12 weeks
Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
次要结局
- Patient QOL(12 weeks)
- Pain Severity(12 Weeks)
- Serum biomarker(12 weeks)
研究者
Alaa Mahmoud Ahmed Shawqy Mahmoud
Principle Invistigator
Future University in Egypt