Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The number of patients with different degree of peripheral nerve toxicity.
研究概览
简要总结
The purpose of this study is to estimate the usefulness and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and safety of the treatment algorithm for 64 patients with colorectal cancer by evaluating the side effects and degree of improvement of subjective symptoms.
详细描述
Oxaliplatin is the third generation platinum-based cytotoxic agent, widely used in colorectal cancer, in metastatic disease and in the adjuvant setting . Moreover, oxaliplatin is being used as an alternative option to cisplatin in various cancers, such as ovarian, gastric. Oxaliplatin-induced peripheral neuropathy is characterised by acute and transient cold hyperaesthesia in the hours and days following oxaliplatin infusion (>90% of patients), but also by retarded chronic neuropathy due to the repetition of chemotherapy cycles (30-50% of patients). Oxaliplatin-induced peripheral neuropathy impairs the health-related quality of life (HRQOL) of patients and no preventive or curative strategies have as yet proven effective so far. Animal experiment show that HD6610 granule can relieve mouse's peripheral neuropathy induced by oxaliplatin. In clinical practice, the investigators also find that HD6610 granule can relieve patient's oxaliplatin-induced peripheral neuropathy in the treatment of chemotherapy. So the investigators design this randomized, parallel-group, double-blind, placebo-controlled, multicenter clinical study to estimate the efficacy and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy in colorectal cancer.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases have been diagnosed with colorectal cancer by pathology;
- •Patients who received no chemotherapy before should receive oxaliplatin-based chemotherapy(FOLFOX4,FOLFOX6,XELOX) ;
- •Patients of 18-70 years old have no serious heart,liver,kidney and hematopoietic disfunction,life expectancy of over 3 months and KPS more than 60;
- •Patients with no positive sign in neurological examination,and no drug allergy history or diabetes;
- •Volunteered to participate and signed informed consent,patients can not receive radiotherapy,acupuncture and moxibustion or other treatment during the experiment.
排除标准
- •Not accordant with the inclusion criteria;
- •Patients who have used herbal within 4 weeks before registration;
- •Patients who have serious heart,liver,kidney and hematopoietic disfunction;
- •Patients of central nervous system disease;
- •Patients of cervical spondylopathy,lumbar disc protrusion,diabetes and uremia which can potentially cause peripheral neuropathy;
- •Nerve compression caused by tumor metastasis or peripheral neuropathy caused by electrolyte disturbances,diabetes,alcohol disease and other disorder;
- •Long-time using of thiazide diuretic and foxglove;
- •Patients of poisoning,infection and radiotherapy which induced peripheral neuropathy or receiving medicine which can cause peripheral neuropathy;
- •Patients who can hardly take Chinese Medicine with severe diarrhea,vomiting or intestinal obstruction ;
- •Uncontrolled psychosis;
- •Women of pregnancy ,preparing pregnant, or lactation;
- •Alcohol and drug abuse;
- •Allergic constitution or allergy to experiment drugs.
研究组 & 干预措施
FOLFOX regimen&HD6610 Granule
Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the HD6610 Granule will be given 2 times a day.
干预措施: FOLFOX regimen (Drug)
FOLFOX regimen&HD6610 Granule
Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the HD6610 Granule will be given 2 times a day.
干预措施: HD6610 Granule (Drug)
FOLFOX regimen&HD6610 Granule placebo
Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule
干预措施: FOLFOX regimen (Drug)
FOLFOX regimen&HD6610 Granule placebo
Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule
干预措施: HD6610 Granule placebo (Drug)
结局指标
主要结局
The number of patients with different degree of peripheral nerve toxicity.
时间窗: Through study completion, an average of 1 year.
次要结局
- EORTC（European Organization for Research and Treatment of Cancer） quality of life score(Through study completion, an average of 1 year.)
- KPS（ Karnofsky Performance Status Scale） score(Through study completion, an average of 1 year.)
研究者
JieGe Huo
Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.
Jiangsu Province Hospital of Traditional Chinese Medicine