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Evaluation of protective effects of silymarin on cisplatin induced nephrotoxicity in patients with upper gastrointestinal adenocarcinoma

Protocol summary

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 manegement, 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. 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 gasterointestinal tract carcinomal randomized to silymarin (520mg) or placebo plus chemotherapy (cisplatin 50-60 mg/m2, 5-FU750 mg/m2, docetaxel 60-80 mg/m2 every 21 days) for 63 day after inclusion. serum creatinin, BUN and electrolyte,NGAL, VEGF, caspase activity assessed at the beginning during and the end of the trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207013043N6
Registration date: 2012-09-09, 1391/06/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-09, 1391/06/19
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of protective effects of silymarin on cisplatin induced nephrotoxicity in patients with upper gastrointestinal adenocarcinoma
Public title
silymarin and cisplatin induced nephrotoxicity
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria (age>18 years; diagnosed and measurale upper gasterointestinal adenocarcinoma; no swallow problem; would like to participate in the study; 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 ACEI; untreated hypo-and hyperthyroidism; ejection fraction<60%; active urinary tract infection; iver disease (5fold increase of liver enzyme in asymptomatic or 3 fold increase in syptomatic; ; use of other nephrotoxic agents such as aminoglycoside, amphotricin; karnofsky performance status <70)
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
tehran university of medical science
Street address
16 azar Avn. tehran university of medical science
City
tehran
Postal code
o21
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
91-03-33-18878

Health conditions studied

1

Description of health condition studied
oesophagus cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus

2

Description of health condition studied
Stomach Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
urine neutrophil gelatinase-associated lipocalin (NGAL)
Timepoint
before chemotherapy and at 6,24 hours after first and third cycle of chemotherapy, day 21 before second cycle
Method of measurement
ELISA kit

2

Description
serum concentration of VEGF and tissue activity of caspase 3
Timepoint
after recruitment and the end of study after three chemotherapy cycle
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy [cisplatin 50-60mg/m2 +5-FU 750 mg/m2 +docetaxel 60-80 mg/m2 control]
Category
Treatment - Drugs

2

Description
placebo 420 mg daily in three divided doses for 65 days as control along with chemotherapy same as intervention
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
cancer institute, imam khomeini hospital
Full name of responsible person
Dr. sanambar sadighi
Street address
cancer institute imam khomeini hospital
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
tehran university of medical science,
Full name of responsible person
Dr.sanambar sadighi, Dr.simin dashti
Street address
cancer institute of tehran, Urology and Nephrology Research Center
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tehran university of medical science,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
dep.clinical pharmacy, tehran university of medical science
Full name of responsible person
Dr. simin dashti-khavidaki
Position
clinical pharmacist
Other areas of specialty/work
Street address
dep.clinical pharmacy, tehran university of medical science
City
tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
dashtis@tums.ac.i
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tums
Full name of responsible person
foroud shahbazi
Position
resident
Other areas of specialty/work
Street address
16 azar Avn. tums
City
tehran
Postal code
Phone
00
Fax
Email
foroud08@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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