At a glance
ClinicalIndex Comparison Record- ✓Stage III or IV colorectal cancer
- ✓Scheduled to receive oxaliplatin as part of mFOLFOX6 chemotherapy regimen
- ✕Renal insufficiency with creatinine clearance <30 mL/min
- ✕Moderate to severe liver impairment (ALT or AST >3× ULN without liver metastases, or >5× ULN with liver metastases)
- ✕Brain metastases present
- ✕Currently uncontrolled cardiac arrhythmias (non-sinus rhythm)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intravenous Lidocaine for Preventing Painful Oxaliplatin-induced Peripheral Neuropathy (OIPN)
In Brief
A Phase 2 clinical trial evaluating Lidocaine Hydrochloride, Placebo, and 1 other intervention for Neuropathy, Painful and 2 related conditions. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW. If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.
Dextrose 5% in water will be administered as active comparator.
Each cycle (repeated every 14 days): Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.