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临床试验/NCT02024191
NCT02024191Unknown3 期

The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial

Ankara Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
2
主要终点
Electromyography parameters

研究概览

简要总结

Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.

详细描述

Our study population includes the colorectal cancer patient who is going to have mFOLFOX6 (modified, Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil l 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) regimen. We randomly assigned the patients into two groups. We administered glutamine at dose of 3x10 gr/day to one patient group concomitantly with mFOLFOX6 regimen and other group had no additional intervention. We performed questionnaire, neurological examination and EMG (Electromyography) before and after 4th cycle of mFOLFOX6 regimen in both patient groups. We planned to compare the neurological signs, symptoms and EMG action potentials between mFOLFOX6+Glutamine and only mFOLFOX6 group. We aimed to search the role of glutamine as a prophylactic agent against oxaliplatin induced neuropathy.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20 - 65 years
  • Operated and non operated colorectal cancer patients
  • Patient administering mFOLFOX 6 ( Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours)

排除标准

  • Patients who had chemotherapy in last 6 months
  • Diabetes Mellitus
  • Sensorimotor polyneuropathy

结局指标

主要结局

Electromyography parameters

时间窗: 4 months interval

Electromyography action potential values will be compared between two patient groups.

次要结局

  • Neurological signs and symptoms(4 months)

研究者

发起方
Ankara Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ozan Yazici

MD

Ankara Education and Research Hospital

研究点 (2)

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