At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
76
Mansoura University
Al Mansurah, Egypt
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)
Time frame: 8 weeks
Time to develop grade 2or 3 PIPN
The time from randomization till development of grade II or III PN will be recorded for all patients included in the study.
Time frame: 8 weeks
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale
Time frame: 8 weeks
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Time frame: 8 weeks
Serum biomarkers level in (ng/mL)
Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.
Time frame: 8 weeks
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