Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of grade II or more peripheral neuropathy
研究概览
简要总结
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.
详细描述
Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms:
- Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering .
- Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >24 years of age, men or women to lower risk of suicidal tendency.
- •Patients with histologically proven cancer
- •Patients receiving oxaliplatin or taxanes-based regimen
- •WHO performance status of 0-2
- •serum AST or ALT no higher than two times the upper limit of normal
- •serum creatinine level less than 2 mg/dL
- •platelet count of at least 100,000/mm3
- •absolute neutrophil count of at least to 1.0 G/L
- •Female patients, those with a negative urine pregnancy test.
排除标准
- •Patients with brain or leptomeningeal metastasis.
- •Patients with previous platinum-based chemotherapy
- •Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
- •Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.
研究组 & 干预措施
Venlafaxine Arm
Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.
干预措施: Venlafaxine 75 MG (Drug)
Gabapentin Arm
Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.
干预措施: Gabapentin 400 mg (Drug)
结局指标
主要结局
The incidence of grade II or more peripheral neuropathy
时间窗: 4 months
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)
次要结局
- The EORTC QLQ-CIPN20 subscales(4 months)
- Pain Severity(4 months)
研究者
Mahmoud Ahmed Mahrous Ali
Head of clinical pharmacy department
Mit Ghamr Oncology Center