The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
研究概览
简要总结
This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .
详细描述
Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing Oxaliplatin induced peripheral neuropathy in cancer patients.
Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible to be enrolled in this study, if they meet the following criteria
- •Elderly males and females with age (˃18 and ˂60).
- •Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.
排除标准
- •Excluded from this study are the patients with the following Criteria:
- •Suffering from diabetes mellitus.
- •Suffering from peripheral neuropathy as a result of any other disease or drug.
- •Suffering from severe renal impairment (CrCl ˂ 30 ml/min).
- •Suffering from epilepsy.
- •Taking vitamin B.
- •Who previously took Oxaliplatin or any other chemotherapeutic agent that causes peripheral neuropathy.
- •Taking antidepressants or MAOI's.
- •Taking NSAIDs, paracetamol, opiates or any other analgesics or pain killers.
- •Pregnant or lactating patients.
研究组 & 干预措施
Treatment group
this arm will receive L-CARNOSINE PO (each patient will receive 1 tablet daily and each tablet contains 500 mg thus a total of 500 mg per day) together with their chemotherapy wich is oxaliplatin.
干预措施: L-CARNOSINE (Drug)
结局指标
主要结局
Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
时间窗: Three months
The following markers will be measured by ELISA kits : Nrf2 induced oxidative stress pathways (GSH) NF-KB anti-inflammatory pathway (TNF- alpha) pro-apoptic signals (caspase 3)
次要结局
- Assessment of tumor markers (CA,CEA) in blood.(Three months)
研究者
Rana Magdy
Teaching assistant
Misr International University