Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- incidence of chronic neurotoxicity
研究概览
简要总结
To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.
详细描述
The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage (according to CSCO guidelines for diagnosis and treatment of colorectal cancer) or III stage, IV stage (metastatic lesions have been radical resection);
- •Patients who are suitable for receiving oxaliplatin plus capecitabine regimen as adjuvant chemotherapy for 6 months, the cumulative dose of oxaliplatin are expected to exceed 520mg/m2 at least;
- •Aged from 18 to 75 years old, males or females;
- •ECOG score ranges from 0 to 1
- •Seven days before treatment, the functions of major organs (heart, liver, kidney, bone marrow) meet the following criteria:
- •Standard of blood routine examination (without blood transfusion within 14 days) i. Hemoglobin (HB) ≥90g/L； ii. Absolute Neutrophil Count(ANC) ≥1.5×109/L；. iii. Platelet (PLT) ≥80×109/L.
- •Biochemical examination should meet the following standards:
- •Total bilirubin(TBIL) ≤1.5 times upper normal limit(ULN);
- •Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) ≤2.5 times ULN；
- •③Serum creatinine （Cr）≤1.5 times ULN or Creatinine clearance(CCr) ≥60ml/min; 6.Expected survival time≥12 months;
- •For subjects who have used other chemotherapeutic drugs in the past, they need to go through a clearance period of at least 4 weeks before entering this trial.
- •The patient who will sign the informed consent form
排除标准
- •Patients with original nervous system diseases, including peripheral neuropathy and central neuropathy;
- •Those who are allergic to oxaliplatin or the ingredients of this traditional Chinese medicine;
- •Clinical symptoms of patients with severe damp-heat syndrome of colorectal cancer include: dry mouth, bitter taste in the mouth, sticky sensation in mouth, yellow urine, dry stool, red tongue with yellow ,thick and greasy fur;
- •Patients with neurological disease caused by electrolyte disorders or diabetes;
- •Patients with symptoms of nerve compression caused by various causes;
- •At the same time, patients who receive other neuroprotective therapy, including nerve growth factor, vitamin B and calcium-magnesium mixture;
- •Patients who were treated with oxaliplatin for chemotherapy before;
- •Patients who need radiotherapy within half a year after operation;
- •Pregnant or lactation period women;
- •Patients with cognitive impairment or psychosis;
- •Other patients the investigator considers unsuitable for inclusion.
研究组 & 干预措施
Single decoction group: Huangqi Guizhi Wuwu decoction
The dosage of granules: Sheng huangqi granule 5.5g/bag, Guizhi granule 0.9g/bag, Baishao granule 1.6g/bag, Ganjiang granule 1.7g/bag, Dazao granule 7g/bag. Take twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)
干预措施: Huangqi Guizhi Wuwu decoction (Drug)
Simulator group: Huangqi Guizhi Wuwu decoction Placebo
The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)
干预措施: Huangqi Guizhi Wuwu decoction (Drug)
结局指标
主要结局
incidence of chronic neurotoxicity
时间窗: 3 years
Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment
次要结局
- Time of occurrence of chronic toxicity(3 years)
- myelosuppression(3 years)
- incidence of acute neurotoxicity(3 years)
- Recovery time of neurotoxicity(3 years)
- main symptoms(3 years)
- nausea, vomiting, diarrhea, and hand-foot syndrome(3 years)
- Cumulative dose of oxaliplatin and the proportion of patients(3 years)