Oxaliplatin induced peripheral neuropathy,OIPN
Conditions
Interventions
Acetyl-L-carnitine group:At the beginning of the first chemotherapy of the oxaliplatin regimen, acetyl levocarnitine 500mg was given orally three times daily for 24 weeks. If the subjects discontinued
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old 2/The Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1 3.The predicted survival time was >=12 months 4.Subjects will receive oxaliplatin-containing regimens, including 1)mFOLFOX6 scheme Oxaliplatin: 85mg/m2 was infused intravenously for 2 hours, day 1; Leucovorin calcium: 400 mg/m^2 was infused intravenously for 2 hours 2 hours, 1 day; 5 - fluorouracil: 400 mg/m^2 static pushed back, the first day, and then 1200 mg (m2, d) continuous intravenous infusion (2400 mg/m^2. total infusion 46-48 h); Every 2 weeks for a cycle of chemotherapy, a total of 12 cycles of chemotherapy. 2)CapeOX scheme Oxaliplatin: 130 mg/m^2 was infused intravenously for 2 hours , 1 day; Capecitabine: 1000 mg/m^2 orally, bid, 1-14 days. Every three weeks for a cycle of chemotherapy, a total of 8 cycles of chemotherapy. 3)FOLFOXIRI scheme Irinotecan: 165 mg/m^2 by intravenous infusion, day 1; Oxaliplatin:85 mg/m^2 by intravenous infusion, day 1; Leucovorin calcium: 400 mg/m^2 by intravenous infusion, day 1; 5 - fluorouracil: 5 - FU 1600 mg/(m^2 · d) x 2 d, continuous intravenous intravenous 48 h (total 3200 mg/m2), 1 day. Every 2 weeks for a cycle of chemotherapy, a total of 12 cycles of chemotherapy. 5.Laboratory values within 7 days before enrollment met the following criteria: Blood routine: neutrophil count (ANC) >=1.5×109/L, platelet count (PLT) >=100×109/L, hemoglobin (HGB) >=80g/L; Liver function: serum total bilirubin (TBIL) = 50ml/min; 6.Patients voluntarily enrolled in the study, provided written informed consent, and adhered to protocol-specified visits and procedures.
Exclusion criteria
Exclusion criteria: 1)Participating in other interventional clinical studies (unless participating in an observational study or in the follow-up phase of an interventional study); 2)Hyponatremia, hypokalemia, hyperchloremic acidosis, adrenal failure and adrenocortical insufficiency (Addison's disease), hepatic coma, diabetes mellitus, brain or leptomeningeal metastases; 3)Patients who had previously received neurotoxic chemotherapy such as taxanes, vinca alkaloids, or cisplatin and received any other medication specifically for the treatment or prevention of neuropathy; 4)Patients with peripheral neuropathy (confirmed by nerve conduction velocity measurements) due to other causes (such as radiation or malignant plexopathy, lumbar or cervical radiculopathy, vitamin B12 deficiency, or diabetes) before chemotherapy; 5)History of alcohol dependence or concomitant use of other drugs known to affect serotonin levels; 6)Having cardiovascular clinical symptoms or disease that is not well controlled; 7)The presence of a mental illness or substance abuse condition that may have affected adherence to trial requirements; 8)Women who are pregnant or lactating 9)There are medical history, disease, treatment, or laboratory abnormalities that may interfere with the results of the trial, prevent the participant from participating in the study throughout, or the researcher believes that participation in the study is not in the best interests of the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of OIPN;Prognosis of tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the occurrence time of OIPN;Severity of OIPN; | — |
Countries
China
Contacts
Public ContactWang Chunlin
Nanfang Hospital, Southern Medical University
Outcome results
None listed