drugset / Trial / NCT05601479

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

NCT05601479

Phase 2 Unknown 100 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2022-11-01
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetylcarnitine Small molecule 500 mg Oral