Providing an appropriate treatment to reduce complications caused by cisplatin
Design
Clinical trial with control group, community based and pragmatic , with parallel groups, not blinded and randomization carried out by using table of numbers, cosist of 30 patients in Phase 3 clinical trial
Settings and conduct
The study is conducted in the hematology department of the Sheikh Hospital and it has not been blinded
Participants/Inclusion and exclusion criteria
Patient satisfaction;
Prescribing cisplatin for the patient;
The absence of kidney disease and any renal failure;
Intervention groups
Intervention group: 15 patients with testicular tumors or head and neck tumors during the course of using cisplatin and 2 days after that they receive vitamin E at a dose of 400 units per day.
Control group: 15 patients with testicular tumors or head and neck tumors who do not take vitamin E supplements during the use of cisplatin.
Main outcome variables
Urinary KIM-1 levels in urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111024007892N8
Registration date:2018-08-02, 1397/05/11
Registration timing:retrospective
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of vitamin E on cisplatin induced nephrotoxicity
Public title
Study the effect of vitamin E on renal complications induced by cisplatin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Prescribing cisplatin for the patient
Patient satisfaction
Exclusion criteria:
Age
From 6 months old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding is not done.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.MUMS.fm..REC.1395.652
Health conditions studied
1
Description of health condition studied
Testicular tumor
ICD-10 code
D40.7
ICD-10 code description
Other male genital organs
2
Description of health condition studied
Head and Neck tumor
ICD-10 code
C49.0
ICD-10 code description
Malignant neoplasm of connective and soft tissue of head, face and neck
Primary outcomes
1
Description
Urinalysis of KIM-1(Kidney Injuri Molecule)
Timepoint
At the beginning of the study and 2 days after the end of vitamin E consumption period
Method of measurement
KIM-1 (Kidney Injuri Molecule) kit of urine sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be given an E Vigel capsule (Dana Pharmacy) at a dose of 400 units daily for up to two days after completion of cisplatin treatment.
Category
Treatment - Other
2
Description
Control group: Patients in the control group not given any substance.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dr.Sheikh Hospital
Full name of responsible person
Anoosh Azarfar
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دکتر محسن تفقدی
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Iman jafarzadeh fadaki
Position
Medical physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
iman.jafarzadeh13@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taheri Ave, Tohid Square, Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
1358- 91735
Phone
+98 51 3726 9021
Email
azarfara@mums.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