Neuroprotective Effect of Neurotropin on Chronic Oxaliplatin-induced Neurotoxicity in Stage II and Stage III Colorectal Cancer Patients: a Randomized, Double-blind, Placebo-controlled, Parallel Grouping Multi-center Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- The incidence of peripheral neurotoxicity among groups
研究概览
简要总结
Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •18 to 75 years old
- •Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
- •should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
- •Agreed and assigned the consent, and was able to receive the baseline assessment
- •Could be inpatient or outpatient participants
排除标准
- •Peripheral neuropathy patients, e.g. diabetes neuropathy
- •Alcoholic related patients
- •Central neuropathy patients
- •Patients who were unable to assess the effectivity and safety
- •Neurotropin allergy
- •History of medications that are contraindicated to neurotropin <28 days before the trial begins
- •Have already received neurotropin tablets more than 4 tablets or 3.6 units <4 weeks before the trials begins
- •Unable to visit the hospital regularly
- •Has been ruled out by investigators
- •Brain tumor or metastasis
- •Brain injury, stroke and brain hemorrhage symptoms occurred during 6 months after sign the consent
- •History of epilepsy, convulsion
- •Severe respiratory, cardiovascular, renal, hepatic or hematologic system(except cancer) disease
- •Depression and other psychologic conditions which investigators recognized as high risk for the enrollment
- •Chronic pain
- •Received other medication from other clinical trials within 28 days
- •Prepare for pregnancy, pregnant, or lactated women
研究组 & 干预措施
Neurotropin 4 tablets/day
All the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.
干预措施: Neurotropin (Drug)
Neurotropin 8 tablets/day
All the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.
干预措施: Neurotropin (Drug)
Placebo
All the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.
干预措施: Placebo (Other)
结局指标
主要结局
The incidence of peripheral neurotoxicity among groups
时间窗: At the end of chemotherapy (up to 8 cycles, each cycle is 21 days)
Oxaliplatin specific neurotoxicity grade classification and assessment. Incidence of Grade 3 or higher peripheral neuropathy at the end of adjuvant chemotherapy
次要结局
- Fine motor functions assessment(From completion of adjuvant chemotherapy, assessed at 2 years.)
- The completion rate of oxaliplatin based chemotherapy(At the end of chemotherapy (up to 8 cycles, each cycle is 21 days))
- Time from total recovery from neurotoxicity after the chemotherapy(From completion of chemotherapy, up to 3 years.)
- Disease-Free Survival (DFS) Rate at 3 Years(From randomization up to 3 years)
- Overall Survival (OS) Rate at 3 Years(From randomization up to 3 years)
研究者
Gong Chen
Professor
Sun Yat-sen University