1)Determination of mean serum creatinine levels, potassium, magnesuim ،BUN and Glomerular filteration rate in patients receiving Cisplatin and patients receiving Cisplatin plus atorvastatin and comparison of both groups
Design
randomized clinical trial, with parallel groups, triple blinded, phase 3, using block randomization
Settings and conduct
setting: Oncology department at Amir Hospital of Shiraz University of Medical Sciences
Triple blind including patients, care providers and data analyser
Participants/Inclusion and exclusion criteria
Inclusion criteria: New cases of patients with solid tumors under Cisplatin therapy, minimum age of 18و glomerular filtration rate (GFR) > 60 ml/min, serum creatinine less than 1.5 mg/dl and both sexes will be included in the study.
Exclusion criteria: Patients who used cisplatin less than 50mg/m2 or divided dose of cisplatin in several days will be excluded in this study. Also patients with a past history of Cisplatin therapy, chronic kidney disease, NSAIDS usage or using any nephrotoxic drugs
Intervention groups
In both groups patients receive 12.5-25 gr manitol in addition to antiemetic medication before receiving cisplatin. Cisplatin infuse in 500 cc chloride serum (N/S) in 1-2 hrs then after finishing infusion of cisplatin the patient hydrate with 500 cc N/S. In second group who receive atorvastatin 40 mg,1 hour before cisplatin administration then continue atorvastatin daily till 7 days after starting cisplatin. patients in first group will recieve placebo like this shedule
Main outcome variables
measuring serum creatinine, BUN, Mg and K at days 1, 8, 21
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140605017982N2
Registration date:2020-06-05, 1399/03/16
Registration timing:registered_while_recruiting
Last update:2020-06-05, 1399/03/16
Update count:0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
Nasrin Namdari
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4301
Email address
namdari_n@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the effect of atorvastatin on the cisplatin induced nephrotoxicity in patients with solid tumors
Public title
investigating the effect of atorvastatin on the cisplatin induced nephrotoxicity
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
New cases of patients with solid tumors under Cisplatin therapy,
minimum age of 18
glomerular filtration rate( GFR) > 60 ml/min
serum creatinine less than 1.5 mg/dl
Exclusion criteria:
Patients who used cisplatin less than 50mg/m2 or divided dose of cisplatin in several days
patients with a past history of Cisplatin therapy, chronic kidney disease, NSAIDS usage or using any nephrotoxic drugs will not participate in this study
patients with a history of NSAIDS usage or using any nephrotoxic drugs will not participate in this study
patients with a historyof chronic kidney disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
3
blood( clot) sample for BUN, cr, K, Mg on days 1, 8 and 21
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will done by blocked randomization method.random blocks of 4 subjects were used. a computer random number generator will generate the sequence of blocks( spss version24, chicago,us). randomization will done by a resident and only he will aware of patients group
Blinding (investigator's opinion)
Triple blinded
Blinding description
we prepared the main drug (atorvastatin) and placebo in 2 different colour of boxes. The patient , care provider and data analyser were blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University Of Medical Science
Street address
Bone Marrow Transplant Ward, Namazee Hospital, Namazee Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7186766781
Approval date
2019-01-14, 1397/10/24
Ethics committee reference number
IR.SUMS.MED.REC.1398.024
Health conditions studied
1
Description of health condition studied
Cisplatin nephrotoxicity
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
percentage of people with renal failure
Timepoint
measurement of blood Urea nitrogen, creatinine, potassium, magnesium before intervention and 8 and 21 days after intervention
Method of measurement
measurement of blood Urea nitrogen, creatinine, potassium, magnesium
Secondary outcomes
empty
Intervention groups
1
Description
Atorvastatin( sobhan) 40 mg,1 hour before cisplatin administration then continue atorvastatin daily till 7 days after starting cisplatin.
Category
Treatment - Drugs
2
Description
Control group: placebo starts 1 hour before starting cisplatin, continue daily for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
َAmir Oncology Hospital
Full name of responsible person
Nasrin Namdari
Street address
Amir Oncology Hospital, Farhang shahr Street, Shiraz,
City
Shiraz
Province
Fars
Postal code
7186766781
Phone
+98 71 3647 4301
Email
namdari_n@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Research and Technology Assistance
Street address
Reasearch and technology assistance, Shiraz university Of medical Science, Namazee Square<, shiraz
City
Shiraz
Province
Fars
Postal code
7186766781
Phone
+98 71 3230 5410
Email
namdrai_n@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Namdari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Bone Marrow Transplant, Namazee Hospital, Namazee Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7186766781
Phone
+98 71 3647 4301
Email
namdari_n@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Namdari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Bone Marrow Transplant Ward, Namazee Hospital, Namazee square, Shiraz
City
Shiraz
Province
Fars
Postal code
7186766781
Phone
+98 71 3647 4301
Email
namdari_n@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Namdari Nasrin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Bone Marrow Transplant Ward, Namazee Hospital, namazee square, Shiraz
City
Shiraz
Province
Fars
Postal code
7186766781
Phone
+98 71 3647 4301
Email
namdari_n@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available