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
Peng Cao
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset, incidence of grade 2 and grade 3 neurotoxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Quality of life assessments;Incidence of Adverse Events;Change from baseline in the EORTC-QLQ-CIPN20 scale and the EORTC QLQ-C30 scale;Chemotherapy effective rate (ORR): ORR=(CR+PR)/total number of cases×100%;Serum NGF concentrations; | — |
Countries
China
Contacts
Public ContactPeng Cao
Outcome results
None listed