Effect of Lidocaine Transdermal Patch as Add-On Therapy in Treatment of Oxaliplatin Induced Peripheral Neuropathy in Colorectal Cancer Patients
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
About this trial
This is an interventional prevention trial for Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
Eligibility Criteria
Inclusion Criteria: Adults with stage II, III and IV colorectal cancers, scheduled to receive an oxaliplatin-based chemotherapy regimen. Patients could be receiving concomitant chemotherapy. Patient ECOG performance status 0-3. Exclusion Criteria: • Pre-existing symmetric peripheral painful neuropathy due to diabetes mellitus or other causes. Presence of brain metastases. Renal insufficiency (calculated creatinine clearance<30ml/min). Moderate to severe hepatic insufficiency (ALTor AST >3times upper level of normal if no liver metastases are present; ALTor AST >5 times upper limit of normal if liver metastases are present). Current uncontrolled cardiac arrhythmias (non-sinus rhythm). Any topical treatment with other medication for neuropathic pain. Pregnancy or breast feeding.
Sites / Locations
- Bangabandhu Sheikh Mujib Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Control Arm
Placebo Arm
This group will consist of 45 patients who are scheduled to receive oxaliplatin based chemotherapy regimen. After receiving 2 cycles of chemotherapy usually patient develops OIPN. Patients who will develop OIPN with pain intensity ≥4 in VAS scores will be included. The patients will be treated with one lidocaine transdermal patch/day for 12 hours for 10 days as add on therapy with standard treatment by oncologist.
This group will consist of 45 patients who are scheduled to receive oxaliplatin based chemotherapy regimen. After receiving 2 cycles of chemotherapy usually patient develops OIPN. Patients who will develop OIPN with pain intensity ≥4 in VAS score will be included. The patients will be treated with one placebo patch/day for 12 hours for 10 days as add on therapy with standard treatment by oncologist.