Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 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, roflumilast 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 75 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
干预措施: Roflumilast (Drug)
Control
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
未报告次要终点
研究者
Noha Mansour
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department
Mansoura University