A multicenter, randomized, double-blind, placebo-controlled phase III clinical study on the prevention of peripheral neurotoxicity of oxaliplatin by yiqiwenjing recipe
- Conditions
- Peripheral neurotoxicity of oxaliplatin
- Registration Number
- ITMCTR2000003507
- Lead Sponsor
- Jiangsu Province Hospital on Integration Chinese and Western Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) All the selected cases were in accordance with the diagnostic criteria of adenocarcinoma of colon in the Chinese standard for diagnosis and treatment of common malignant tumors issued by the Ministry of health, and were confirmed by pathology;
2) All patients were treated with adjuvant chemotherapy after radical resection of colon cancer. The chemotherapy regimen was FOLFOX4, mFOLFOX6 or XELOX. Oxaliplatin was used 85mg/m2 once every two weeks (8-12 times);
3) The predicted survival time was more than 6 months;
4) Aged >= 18 years;
5) No severe damage to the center of gravity, liver, kidney or hematopoietic system.
1) At present, there are any grade of peripheral neuropathy;
2) Having previously received chemotherapy drugs with neurotoxicity, such as oxaliplatin, cisplatin, taxanes or vinblastine alkaloids;
3) We are receiving carbamazepine, phenytoin sodium, valproate sodium, gabapentin, pregabalin, venlafaxine, norvenlafaxine, minapram, duloxetine, tricyclic antidepressants and other drugs that may have therapeutic or preventive effects on neuropathy;
4) Participate in any other clinical study;
5) There is a family history of hereditary/familial neuropathy.
6) Patients who can't take medicine orally;
7) Patients with mental illness who cannot cooperate;
8) Pregnant women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EORTC QLQ-CIPN20;NCI-CTCAE 4.0;
- Secondary Outcome Measures
Name Time Method Peripheral blood was used to detect neurotoxicity related indexes, such as TNF a and NGF;Evaluation of chemotherapy efficacy (RESIST 1.1);Number of chemotherapy cycles completed;EORTC QLQ-C30;