To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.
The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).
Affiliated Hospital of Nanjing University of TCM
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGincidence of chronic neurotoxicity
Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment
Time frame: 3 years
incidence of acute neurotoxicity
Difference in the incidence of acute neurotoxicity
Time frame: 3 years
Time of occurrence of chronic toxicity
Time of occurrence of chronic toxicity to grade 2 and 3
Time frame: 3 years
main symptoms
Incidence and severity of main symptoms
Time frame: 3 years
Recovery time of neurotoxicity
Recovery time of grade 2 and 3 neurotoxicity
Time frame: 3 years
Cumulative dose of oxaliplatin and the proportion of patients
Cumulative dose of oxaliplatin and the proportion of patients who stop using oxaliplatin because of neurotoxicity
Time frame: 3 years
myelosuppression
Incidence of myelosuppression
Time frame: 3 years
nausea, vomiting, diarrhea, and hand-foot syndrome
Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.