drugset / Trial / NCT03254394

Lidocaine for Oxaliplatin-induced Neuropathy

NCT03254394

Phase 1/2 Completed 26 enrolled Washington University School of Medicine
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of long-term neuropathy. In this study, the investigators aim to determine whether intravenous lidocaine can prevent oxaliplatin-induced cold hypersensitivity.

Timeline

Start
2017-09-15
Primary completion
2020-09-28
Completion
2021-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 5.8 mg/kg Intravenous
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 1200 mg/m2 Intravenous