ITMCTR2000003307尚未招募1 期
Effects of External Application of Traditional Chinese Medicine He-Xue Tong-Bi Powder on Oxaliplatin-Induced Peripheral Neuropathy Among Patients With Colorectal Cancer: an Open-Label, Randomized Controlled Trial
The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 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
- Interventional study
入排标准
- 性别
- All
入选标准
- •1. When the subjects signed the informed consent, they were >= 18 years old, both male and female;
- •2. Patients with colorectal cancer confirmed by histology or cytology;
- •3. Patients who have not received oxaliplatin before;
- •4. Patients with ECoG PS 0-2;
- •5. Patients with life expectancy >= 3 months;
- •6. Patients who are willing to comply with the requirements of informed consent can use drugs according to the doctor's orders and receive regular follow-up,;
- •7. Patients who can complete the questionnaire by themselves or with assistance;
- •8. Patients who are in line with the indications of chemotherapy and intend to receive oxaliplatin chemotherapy;
- •9. Blood analysis and examination: (no blood transfusion, no use of G-CSF, no use of drug correction within 14 days before screening);
- •(1) Hemoglobin (HB) >= 90 g / L;
- •(2) The absolute value of neutrophil count (ANC) >= 1.5 x 10^9 / L;
- •(3) Platelet count (PLT) >= 100 x 10^9 / L;
- •(4) WBC >= 4.0 x 10^9 / L and <= 15 x 10^9 / L.
- •10. Biochemical examination: (no blood transfusion or albumin within 14 days before screening);
- •(1) AST and alt <= 1.5 times of upper limits of normal (ULN) (if there is tumor liver metastasis, < 5 times of ULN);
- •(2) ALP <= 2.5 times ULN (in case of tumor bone metastasis, < 5 times ULN);
- •(3) TBIL <= 1.5 times ULN;
- •(4) ALB >= 30g/L;
- •(5) Cr <= 1.5 times ULN, Cr Cl >= 60 ml / min (Cockcroft Gault formula);
- •(6) APTT <= 1.5 times ULN and INR or PT <= 1.5 times ULN (no anticoagulation treatment);
- •11. Women of childbearing age must be defined as not pregnant before the first medication. Women of childbearing age and male subjects with partners of women of childbearing age must agree to use effective contraceptive methods during the study and within 180 days after the last administration of the study drug.
排除标准
- •1. Patients with other neuropathy;
- •2. Diabetic patients with bone and joint diseases and peripheral sensory abnormalities;
- •3. Patients with peripheral neuropathy caused by poisoning, infection, radiotherapy, etc;
- •4. Patients with other skin diseases;
- •5. Patients who need to receive other drugs that may change the symptoms of peripheral nervous system during the treatment;
- •6. Patients with allergic constitution or allergy to related traditional Chinese medicine;
- •7. Subjects with mental illness, alcoholism, inability to quit smoking, drug use or drug abuse were excluded;
- •8. Subjects with any disease, treatment or laboratory history or current evidence that may confuse the results of the study, interfere with the subject's participation in the study procedure or not in the best interest of the subject's participation in the study are excluded according to the judgment of the investigator.
研究者
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