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Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity

Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Upper GI Cancer, Cisplatin Adverse Reaction

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Trial Information

Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity

This study will look for possible protective effects silymarin on kidney injury in patients
receiving cisplatin.

Inclusion Criteria:

- age>18 years

- diagnosed

- measurable upper gastrointestinal adenocarcinoma

- swallow problem

- would like to participate in the study

- Glomerular filtration rate(GFR)>45ml/min/1.73m2

Exclusion Criteria:

- end stage renal disease

- requiring dialysis

- post transplantation

- receiving contrast media during last 72 hours

- chronic use of corticosteroids

- chronic use of angiotensin-converting enzyme inhibitor(ACEI )

- untreated hypo-and hyperthyroidism

- ejection fraction<60%

- active urinary tract infection

- iver disease ( five fold increase of liver enzyme in asymptomatic or 3 fold increase
in symptomatic

- use of other nephrotoxic agents such as aminoglycoside, amphotericin

- karnofsky performance status <70

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Urine concentration of NGAL

Outcome Description:

All subject receive silymarin at dose of 420mg or placebo in three dose for 65 consecutive day, urine NGAL concentration will be measured.

Outcome Time Frame:

up to 9 weeks

Safety Issue:



Iran: Ethics Committee

Study ID:




Start Date:

April 2013

Completion Date:

September 2015

Related Keywords:

  • Upper GI Cancer
  • Cisplatin Adverse Reaction
  • cisplatin
  • nephrotoxicity
  • antioxidant
  • urine neutrophil gelatinase-associated lipocalin (NGAL)