Status:

COMPLETED

Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma

Lead Sponsor:

Tehran University of Medical Sciences

Conditions:

Upper GI Cancer

Cisplatin Adverse Reaction

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

PHASE3

Brief Summary

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 adve...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2014

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01829178

Start Date

August 1 2013

End Date

September 1 2014

Last Update

May 13 2015

Active Locations (1)

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Tehran University of Medical Science

Tehran, Tehran Province, Iran