The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in average daily pain intensity
研究概览
简要总结
This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.
All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.
The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).
The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)
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
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients, 18 years of age or older, with a cancer treated with Paclitaxel
- •Patients must have a life expectancy of at least 24 weeks.
- •Patients must sign an informed consent.
- •Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
- •Patient matching high risk on the CIPN risk stratification scoring system
排除标准
- •Patients with symptomatic brain metastases.
- •Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent complementary medicines during this study.
- •Patients with neuropathy induced diabetes.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.
研究组 & 干预措施
Venlafaxine Treated Arm
干预措施: Venlafaxine (Drug)
Memantine Treated Arm
干预措施: Memantine (Drug)
结局指标
主要结局
Change in average daily pain intensity
时间窗: 6 weeks
Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).
Electrophysiological studies
时间窗: 6 weeks
nerve conduction velocity at the end of the study
次要结局
未报告次要终点
研究者
G Fadl
Dr
Cairo University