Preventive Effect of Acetyl-L-carnitine on Oxaliplatin-induced Peripheral Neuropathy

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

With the prolongation of the overall survival time of patients with malignant tumors, the influence of oxaliplatin on the quality of life of patients with malignant tumors has gradually become prominent. Studies have shown that acetyl-L-carnitine can improve the energy metabolism of neurotransmitters and inhibit the release of glutamine in the intersynaptic space to reduce pain. Large-scale clinical studies have approved it as a treatment for diabetic peripheral neuropathy. Some small model studies have also found that acetyl-L-carnitine has a definite therapeutic effect on peripheral neurological lesions induced by chemotherapy. The aim of this study is to investigate the safety and efficacy of acetyl-L-carnitine in the prevention of oxaliplatin-induced peripheral neuropathy. The study was divided into an experimental group and a control group. The experimental group was given acetyl-L-carnitine orally, and the researchers regularly evaluated the symptoms and electrophysiological indicators related to peripheral neuropathy. If there is a severe adverse reaction related to acetyl-L-carnitine, the drug should be discontinued and the symptomatic treatment should be given. After the completion of the study, the statistical calculation and analysis will be used to estimate whether the preventive and therapeutic effect of acetyl-L-carnitine on oxaliplatin-induced peripheral neuropathy was statistically significant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Acetylcarnitine

Criteria

Inclusion Criteria:

• Age ≥18 years old

• The Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1

• The predicted survival time was ≥12 months

• Subjects will receive oxaliplatin-containing regimens, including

• mFOLFOX6 scheme Oxaliplatin: 85mg/m2 was infused intravenously for 2 hours, day 1; Leucovorin calcium: 400 mg/m2 was infused intravenously for 2 hours, 1 day; 5 - Fluorouracil: After 400mg/m2 intravenous bolus on day 1, then 1200mg (m2•d) continuous intravenous pump infusion (total 2400mg/m2, infusion 46-48h); Chemotherapy will be performed every 2 weeks for 12 cycles.

• CapeOX scheme Oxaliplatin: 130 mg/m2 was infused intravenously for 2 hours, day 1; capecitabine: 1000 mg/m2 orally, bid, 1-14 days; Chemotherapy will be performed every 3 weeks for 8 cycles.

• FOLFOXIRI scheme Irinotecan: 165 mg/m2 was infused intravenously, day 1; Oxaliplatin:85mg/m2 was infused intravenously, day 1; Leucovorin calcium: 400 mg/m2 was infused intravenously, day 1; 5 - Fluorouracil: The total dose of 5-FU was 2400-3200 mg/m2, and the intravenous infusion lasted for 48 hours, day 1; Chemotherapy will be performed every 2 weeks for 12 cycles.

• Laboratory values within 7 days before enrollment should meet 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) ≤ 1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal; Renal function: creatinine clearance (CCr) ≥ 50ml/min;

• Patients should voluntarily participant in the study, provide written informed consent, and adhere to protocol-specified visits and procedures.

Exclusion Criteria:

• Participating in other interventional clinical studies (unless participating in an observational study or in the follow-up phase of an interventional study);

• Hyponatremia, hypokalemia, hyperchloremic acidosis, adrenal failure and adrenocortical insufficiency (Addison's disease), hepatic coma, diabetes mellitus, brain or leptomeningeal metastases;

• Patients who has previously received neurotoxic chemotherapy such as taxanes, vinca alkaloids, or cisplatin and received any other medication specifically for the treatment or prevention of neuropathy;

• 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;

• History of alcohol dependence or concomitant use of other drugs known to affect serotonin levels;

• Having cardiovascular clinical symptoms or disease that is not well controlled;

• The presence of a mental illness or substance abuse condition that may have affected adherence to trial requirements;

• Women who are pregnant or lactating;

• 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.