A Phase 2/3 interventional study of Silymarin and Placebo in Upper GI Cancer and Cisplatin Adverse Reaction, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-05-13.
Sponsored by Tehran University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Placebo 420 mg daily in three divided doses for 65 days as control along with \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2\]
Drug: Placebo · Drug: chemotherapy
silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2 control
Drug: Silymarin · Drug: chemotherapy
Silymarin 420 mg in 3 divided dose plus standard chemotherapy
Also known as: Milk thistle
placebo tablets: 420 mg in 3 divided dose
Also known as: Identical inert tablet to mimic silymarin (140 mg)
All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2
Also known as: Cisplatin, fluorouracil, Docetaxel
Urine concentration of NGAL
All subject receive silymarin at dose of 420mg or placebo in three dose for 65 consecutive day, urine NGAL concentration will be measured.
Time frame: up to 9 weeks
Changes in VEGF Serum concentration
To assess interaction between silymarin and cancer chemotherapy serum vascular endothelial growth factor will be measured.
Time frame: up to 9 weeks
Tissue activity of caspase 3
To assess interaction between silymarin and cancer chemotherapy Tissue activity of caspase 3will be measured.
Time frame: up to 9 weeks
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences