Lidocaine for Oxaliplatin-induced Neuropathy (NCT03254394) | Clinical Trial Compass
CompletedPhase 1/2
Lidocaine for Oxaliplatin-induced Neuropathy
United States26 participantsStarted 2017-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time