Status:
COMPLETED
Lidocaine for Oxaliplatin-induced Neuropathy
Lead Sponsor:
Washington University School of Medicine
Conditions:
Neuropathy, Painful
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Colorectal cancer is the third leading cause of cancer death in the United States, with an estimated incidence of 130.000 cases per year. Oxaliplatin is the first-line chemotherapy regimen for gastro-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03254394
Start Date
September 15 2017
End Date
April 1 2021
Last Update
March 9 2022
Active Locations (1)
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1
Washington University School of Medicine/Barnes Jewish Hospital
St Louis, Missouri, United States, 63110