This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.
This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer. This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups: Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months). Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months). Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
93
Duloxetine 30mg / day for 12 cycles (up to 6 months)
Gabapentin 300 mg / day for 12 cycles (up to 6 months)
Lacosamide 50 mg / day for 12 cycles (up to 6 months)
Oncology Department, Tanta University
Tanta, Egypt
McGill Pain Questionnaire
questionnaire
Time frame: every 2 weeks
12-item neurotoxicity questionnaire
questionnaire
Time frame: every 4 weeks
EORTC Core Quality of Life questionnaire
questionnaire
Time frame: up to 6 months
Common Terminology Criteria for Adverse Events
questionnaire
Time frame: every 4 weeks
Neurofilament light chain (NfL)
biological biomarker
Time frame: up to 6 months
Nuclear factor- kappa B (NF- κB)
biological biomarker
Time frame: up to 6 months
Neurotensin (NT)
biological biomarker
Time frame: up to 6 months
Hemeoxygenase-1
biological biomarker
Time frame: up to 6 months
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