Evaluation of Melatonin protective effects on the Cisplatin nephrotoxicity by kidney injury molecule-1 (Kim-1) , Neutrophil gelatinase-associated lipocalin (NGAL) and serum creatinine measurement.
Design
Randomized, double-blinded, parallel, placebo-controlled clinical trial with 25 patients in each group.
Settings and conduct
This double blind study will be done in order to evaluation of nephroprotective effects of Melatonin by NGAL , KIM-1 and serum creatinine measurement . Researcher and patients are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
≥ 18 years of age
Cancer patients who receive Cisplatin with ≥50 mg/m2 of dose in one day and the chemotherapy courses are repeated every 3 weeks
Patients with one of lung، head and neck، genitourinary system, gastrointestinal cancers
Glomerular filtration rate (GFR)>45 ml/min ( modification of diet in renal disease (MDRD) formula)
Exclusion criteria:
Patients with kidney cancer
The history of using other nephrotoxic drugs within the previous 2 weeks
Intervention groups
Treatment group: patients who receive Melatonin
Control group: patients who receive placebo
Main outcome variables
Urine NGAL , urine KIM_1 , urine creatinine and serum creatinine and BUN
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038073N1
Registration date:2018-08-30, 1397/06/08
Registration timing:registered_while_recruiting
Last update:2018-08-30, 1397/06/08
Update count:0
Registration date
2018-08-30, 1397/06/08
Registrant information
Name
Elliyeh Ghadrdan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6609 9223
Email address
el-ghadrdan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of nephroprotective effects of Melatonin in cancer patients treated with Cisplatin
Public title
Evaluation of nephroprotective effects of Melatonin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
≥ 18 years of age
Cancer patients who receive Cisplatin with ≥50 mg/m2 of dose in one day and the chemotherapy courses are repeated every 3 weeks
Patients who do not use other nephrotoxic chemotherapy drugs
Glomerular filtration rate (GFR)>45 ml/min (modification of diet in renal disease (MDRD) formula)
Patients with one of lung، head and neck، genitourinary system, gastrointestinal cancers
Karnofsky status ≥ 60%
Normal liver function
Exclusion criteria:
Kidney cancer
Inability to take oral medication
Heart failure
Active infection
The history of using other nephrotoxic drugs (e.g. Vancomycin, Aminoglycoside, Amphotericin and NSAID) within the previous 2 weeks
The patients who are using angiotensin-converting-enzyme inhibitor (ACE inhibitor) & angiotensin receptor blockers (ARB) medicines
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block randomization
Unit of randomization: individualized
Randomization by statistical software
Allocation concealment :numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and data collector: blinded because the researcher is unaware of the contents of the can
Patients: blinded because they are unaware of the contents of the can
Health care personnel: blinded because they are unaware of the contents of the can
Data analyser: unblinded
Writer of the article draft: blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the institute of pharmaceutical sciences Tehran university of medical sciences
Street address
Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
0
Approval date
2018-04-23, 1397/02/03
Ethics committee reference number
IR.TIPS.REC.1397.016
Health conditions studied
1
Description of health condition studied
Lung، head and neck، genitourinary system or gastrointestinal cancers
ICD-10 code
C7, C8 ,
ICD-10 code description
C07 Malignant neoplasm of parotid gland , C08 Malignant neoplasm of other and unspecified major salivary glands, C09 Malignant neoplasm of tonsil , C10 Malignant neoplasm of oropharynx, C11 Malignant neoplasm of nasopharynx, C12 Malignant neoplasm
Urine NGAL level measurement dose before Cisplatin administration , 6 h and 24 h after
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) method
2
Description
Urine Kidney Injury Molecule-1 (KIM-1) level
Timepoint
Urine KIM1 level measurement dose before Cisplatin administration , 6 h and 24 h after
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) method
3
Description
Serum creatinine level
Timepoint
Serum creatinine level measurement dose before Cisplatin administration and 72 h after
Method of measurement
Jaffe method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Melatonin with dose of 20 mg (two Melatonin 10 mg tablets) from Best naturals company will be prescribed every night from at least 1 day before Cisplatin administration to one week period.
Category
Prevention
2
Description
Control group: Two tablet of Placebo will be prescribed every night from at least 1 day before Cisplatin administration to one week period.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
cancer institute of Imam Khomeini hospital
Full name of responsible person
Zahra Jahangard Rafsanjani
Street address
Keshavarz Ave., Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
el-ghadrdan@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Jahangard-Rafsanjani
Street address
16 azar Ave, Keshavarz Ave,
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6658 1692
Email
el-ghadrdan@razi.tums.ac.ir
Grant name
Research committee of Tehran university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Jahangard-Rafsanjani
Position
ََAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
zjahangard@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Jahangard-Rafsanjani
Position
ََAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
zjahangard@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elliyeh Ghadrdan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No.4,Golbon 5 Allay., Sargord Rezaei dehghan Ave
City
Tehran
Province
Tehran
Postal code
1341674146
Phone
+98 21 6609 9223
Fax
Email
el.ghadrdan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data like patient lab data and effects of Melatonin and side effects of chemotherapy will be published in form of article
When the data will become available and for how long
At the end of study and after publication
To whom data/document is available
Scientific researchers
Under which criteria data/document could be used
For more researches
From where data/document is obtainable
Zahra Jahangard-Rafsanjani
What processes are involved for a request to access data/document