Lidocaine for Oxaliplatin-induced Neuropathy

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Lidocaine; Oxaliplatin

Criteria

Inclusion Criteria:

• Stage III and IV colorectal cancer.

• Scheduled for oxaliplatin treatment in mFOLFOX6-based chemotherapy regimen.

• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• Renal insufficiency (defined as calculated Creatinine clearance < 30mL/min)

• Moderate to severe liver failure (defined as ALT or AST > 3 times upper limit of normal if no liver metastases are present; ALT or AST > 5 times upper limit of normal if liver metastases are present).

• Presence of brain metastases.

• Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm).

• Patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in "contra-indicated medications".

• Contraindication or allergy to intravenous lidocaine.

• Pre-existing symmetric peripheral painful neuropathy.

• Treated with chemotherapy within the past 12 months.

• Pregnancy or breastfeeding

• Currently treated with any of the following contraindicated medications: Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine, Mexiletine (and other types of sodium-channel blocker antiarrhythmics), Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine, Amiodarone, Dronedarone, Dihydroergotamine, Cimetidine