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NCT Number: NCT01829178

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

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.

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Key information

Conditions

Upper GI Cancer Cisplatin Adverse Reaction Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tehran University of Medical Science

Tehran, Tehran Province, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silymarin

Drug

Silymarin 420 mg in 3 divided dose plus standard chemotherapy

Other names: Milk thistle

Placebo

Drug

placebo tablets: 420 mg in 3 divided dose

Other names: Identical inert tablet to mimic silymarin (140 mg)

Chemotherapy

Drug

All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2

Other names: Cisplatin, fluorouracil, Docetaxel

Primary outcomes

  1. Urine concentration of NGAL

    Time frame: up to 9 weeks

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

Secondary outcomes

  1. Changes in VEGF Serum concentration

    Time frame: up to 9 weeks

    To assess interaction between silymarin and cancer chemotherapy serum vascular endothelial growth factor will be measured.

  2. Tissue activity of caspase 3

    Time frame: up to 9 weeks

    To assess interaction between silymarin and cancer chemotherapy Tissue activity of caspase 3will be measured.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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