Phase 2
N=26
Lidocaine for Oxaliplatin-induced Neuropathy
Neuropathy, Painful · Chemotherapy-induced Peripheral Neuropathy · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03254394 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time — 16.4; 9.5; 33.1; 25.4 score on a scale*days — p=0.318
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lidocaine Hydrochloride (Drug); Placebo (Drug); FOLFOX regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time |
16.4; 9.5; 33.1; 25.4 | 0.318 |
| SECONDARY CIPN Score on EORTC QLQ-CIPN20 |
2; 4; 17.0; 37.0 | 0.338 |
| SECONDARY Changes in NPSI Score. |
0; 0; 0; 0; 3.0; 13.5 | 0.581 |
| SECONDARY The Cumulative Dose of Oxaliplatin |
1161.8; 1294.8 | 0.730 |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03254394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.