ITMCTR2100005444尚未招募2 期
Clinical efficacy and mechanism of oxaliplatin neurotoxicity by chemotherapy sequential warming and toning formula
Peng Cao0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Treatment study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Those who meet all of the following criteria will be selected.
- •1. age: between 18 and 75 years, regardless of gender
- •2. patients with a diagnosis of colorectal cancer confirmed by pathological histological examination
- •3. patients receiving the oxaliplatin regimen for the first time and developing grade 1 peripheral neurotoxicity (patients did not develop peripheral neurotoxicity before receiving the CapeOX regimen for the first time).
- •4. routine blood: absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, hemoglobin = 90 g/L
- •5. liver function: ALT = 3 times the upper limit of normal (ULN), AST = 3 times the upper limit of normal (ULN), bilirubin = 1.5 times the upper limit of normal (ULN)
- •6. renal function: creatinine = 1.5 times the upper limit of normal (ULN).
- •7. normal blood calcium and magnesium.
- •8. no history of concomitant heart block or heart block.
- •9. no family history of genetic/familial neuropathy.
- •10. ability to take oral medications.
- •11. no alcohol addiction or dependence.
- •12. expected survival of = 6 months
- •13. patients who voluntarily sign a written informed consent form.
排除标准
- •Exclusion is required if any of the following criteria are met.
- •1. hypersensitivity to platinum, fluorouracil and the composition of Huangqi Wuwu Tang
- •2. patients with brain metastases.
- •3. pre-existing neuropathic disease (e.g., diabetic peripheral neuropathy, VB12 deficiency, thyroid dysfunction, AIDS, post-surgical/post-traumatic neuropathy, etc.)
- •4. pre-existing neurodegenerative disease (e.g. Parkinson's, Alzheimer's, Huntington's) or neuromuscular disease (e.g. multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease), history of epilepsy
- •5. taking other drugs that induce neurotoxicity (e.g., vincristine, perphenazine, paclitaxel, docetaxel, cytarabine, thalidomide, bortezomib, carboplatin, cisplatin, or procarbazine) during the use of the CapeOX regimen.
- •6. treatment with any other investigational drug or participation in another clinical trial within 4 weeks prior to the first administration of the trial drug.
- •7. taking neuroprotective drugs (e.g., monoamine oxidase inhibitors, antidepressants, anticonvulsants, neurotrophic factors, vitamins, etc.) during the use of the CapeOX regimen
- •8. use of digitalis analogues within 2 weeks.
- •9. uncontrolled infections.
- •10. pregnant or lactating women, or women of childbearing age with positive pregnancy test results; male or female patients who are not using effective contraception or who plan to conceive (inseminate) within 6 months of the start of the trial
- •11. other patients who, in the opinion of the investigator, are not suitable for enrollment.
研究者
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