This randomize controlled clinical trial will be conducted to evaluate the effect of vitamin E on bladder cancer recurrence. Patients diagnose with a single, low-grade, superficial bladder tumor of less than 3 cm in diameter will be included in the study; Patients with accompanying carcinoma insitu (CIS) are excluded from the study. The patients will be randomly divided into two groups( randomization are simple as one among in referring order); one with oral intake of vitamin E (400 IU daily at night before sleep) and the control group with no intervention. None of the patients receive intravesical chemotherapy. The main outcome is recurrence rate and will be compared between two groups. The patients will be followed every three months with urine analysis and bladder ultrasound. Cystoscopy will be performed for microscopic hematuria or urinary symptoms during follow up. Cystoscopy will be done for all patients in the third- and the twelfth- month- follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105235527N2
Registration date:2011-05-25, 1390/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-25, 1390/03/04
Registrant information
Name
Hamidreza Zia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 311625555
Email address
hamidzia@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-02-04, 1388/11/15
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin E on superficial bladder cancer recurrence
Public title
Effect of vitamin E on bladder cancer recurrence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with a single, low-grade, superficial bladder tumor of less than 3 cm in diameter
Exclusion criteria:
Patients with accompanying carcinoma insitu(CIS)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science, hezar jirib street
City
Isfahan
Postal code
Approval date
2010-02-02, 1388/11/13
Ethics committee reference number
388477
Health conditions studied
1
Description of health condition studied
Bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Bladder cancer recurrence
Timepoint
Every 3 months
Method of measurement
Cystoscopy, urine analysis and sonograghy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after transurethral resection of bladder tumor intake of vitamin E (400 IU daily at night before sleep) and follow up every 3 months
Category
Treatment - Drugs
2
Description
Control group: after transurethral resection of bladder tumor no medication intake, cystoscopy and sonography done every 3 months
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery for Research, Isfahan University of Medical Sciences
Full name of responsible person
Mrs.Toghyani
Street address
Isfahan University of Medical Sciences, Hezar jerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research, Isfahan University of Medical Sciences
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
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamidreza Zia
Position
Resident of urology
Other areas of specialty/work
Street address
Alzahra hospital, Shohadae sofe street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
hzyia@yahoo.com; hamidzia@residen.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamid Mazdak
Position
Assistant professor, Urologist
Other areas of specialty/work
Street address
Alzahra hospital, Shohadae sofe street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
mazdak@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Hamidreza Zia
Position
Resident of urology
Other areas of specialty/work
Street address
Alzahra hospital, Shohadae sofe street, Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
hzyia@yahoo.com; hamidzia@residen.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)