Safety and Efficacy of Cilostazol in Prevention of Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
研究概览
简要总结
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, cilostazol potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status from 0 to
- •Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
排除标准
- •Patients with signs and symptoms of clinical neuropathy at baseline.
- •Patients with diabetes mellitus or alcoholic disease.
- •Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
研究组 & 干预措施
Intervention
Cilostazol 100 mg twice daily for treatment period
干预措施: Cilostazol (Drug)
Control
placebo twice daily for treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
时间窗: 8 weeks post intervention
Number of patients reported neuropathy from paclitaxel
次要结局
- Severity of chemotherapy induced-peripheral neuropathy(8 weeks)
- Serum malionaldehyde(8 weeks)
- the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale(8 weeks)
- Serum nerve growth factor(8 weeks)
研究者
Noha Mansour
Lecturer of Clinical Pharmacy
Mansoura University