Peripheral neurotoxicity caused by oxaliplatin for colorectal cancer chemotherapy
Conditions
Interventions
Granule group:Subjects were given Huangqi Gui Zhi Wu Wu Wu Tang granules twice a day, once in the morning and once in the evening, one sachet each time, with warm water
Sponsors
Jiangsu Institute of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years, male or female; 2. Patients with colorectal cancer diagnosed by histopathological examination; 3. Patients who received oxaliplatin for the first time and had grade 1 peripheral neurotoxicity (the patients did not have peripheral neurotoxicity before receiving CapeOX for the first time); 4. Blood routine: absolute neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 90g/L; 5. Liver function: ALT= 6 months 13. Patients who voluntarily signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastases; 2. Pre-existing neuropathy (eg, diabetic peripheral neuropathy, VB12 deficiency, thyroid dysfunction, AIDS, post-operative/post-traumatic neuropathy, etc.); 3. Pre-existing neurodegenerative disease (eg Parkinson's, Alzheimer's, Huntington's) or neuromuscular disease (eg multiple sclerosis, amyotrophic lateral sclerosis, polio, genetic neuromuscular disease), a history of epilepsy; 4. Taking other neurotoxic drugs (eg, vincristine, vinblastine, paclitaxel, docetaxel, cytarabine, thalidomide, bortezomib, carboplatin, cisplatin or carbazide); 5. Treatment with any other investigational drug within 4 weeks prior to the first use of the investigational drug, or participation in another clinical trial; 6. Taking neuroprotective drugs (such as monoamine oxidase inhibitors, antidepressants, anticonvulsants, neurotrophic factors, vitamins, etc.) during the use of the CapeOX regimen; 7. Have used digitalis drugs within 2 weeks; 8. Uncontrolled infection; 9. Women who are pregnant, breastfeeding, or women of childbearing age have a positive pregnancy test result; male or female patients who do not take effective contraceptive measures, or who plan to conceive (give) within 6 months after the start of the trial; 10. Other patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset, incidence of grade 2 and grade 3 neurotoxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Progression-free survival (PFS);Chemotherapy effective rate ;Quality of life assessments;Serum NGF concentrations;Change from baseline in the EORTC-QLQ-CIPN20 scale and the EORTC QLQ-C30 scale; | — |
Countries
China
Contacts
Public ContactCao Peng
Jiangsu Institute of Traditional Chinese Medicine
Outcome results
None listed