A randomized, controlled , double-blind clinical study on the prevention and treatment of peripheral neurotoxicity of oxaliplatin by Danggui Sini granule
- Conditions
- Peripheral neurotoxicity of oxaliplatin
- Registration Number
- ITMCTR2000004124
- 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 colorectal cancer and were confirmed by pathology or cytology with stage II-IV;
2. Karnofsky score above 60, the predicted survival time was more than 4 months;
3. Aged 18-80 years;
4. No severe damage to the center of gravity, liver, kidney or hematopoietic system;
5. Volunteer to participate in clinical research and sign the informed consent.
1. with any grade of peripheral neuropathy;
2. Having received chemotherapy drugs with neurotoxicity in one month, 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. A history of second or third degree atrioventricular block;
5. Participate in any other clinical study of preventing and treating neurotoxicity;
6. There is a family history of hereditary/familial neuropathy;
7. Patients with severe infection;
8. Patients with mental illness;
9. Pregnant women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CI-CTCAE 4.0;
- Secondary Outcome Measures
Name Time Method EORTC QLQ-CIPN20;The function of median nerve and peroneal nerve was detected by electromyography;KPS;