Overview

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