Cisplatin Adverse Reaction Clinical Trial
Official title:
Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity
Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid
tumours. acute renal failure, despite conservative fluid and electrolyte management,
frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan
complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective,
anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated
lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to
cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor,
vascular endothelial growth factor and insulin-like growth factor-I have shown in the
previous in-vitro studies.The aim of present study,a randomized double-blind placebo-
controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin
induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed
upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus
chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21
days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and
urine electrolyte will be measured daily during chemotherapy.
changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity
assessed up to 64 days.
This study will look for possible protective effects silymarin on kidney injury in patients receiving cisplatin. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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