This study will performed in oncology and radiotherapy ward of Imam Reza hospital, affiliated to Mashhad University of Medical Sciences, Mashhad, Iran. Patients, clinical oncologist, pharmacy student, and clinical pharmacy will be blind in this study about medicine or placebo allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Intermediate_risk cancer with Gleason score<8 ; Life expectancy more than 10 years.
Exclusion criteria: Patient with history of chemotherapy, radiotherapy or hormone therapy ; patients with chronic liver, kidney or heart disease ; patient with diabetes mellitus ; patient with autoimmune disease ; hypersensitivity to silymarin ; using anti inflammatory drugs or other antioxidant ; patient disagreement
Intervention groups
Intervention group: prescribing of Silymarin oral solution (140mg silymarin/cc) four times a day and each time 1cc after meal to patient with non metastatic prostate cancer after radical prostatectomy and Placebo group: prescribing of 1 cc placebo solution with same appearance only without effective ingredient after meal, four times a day to patient with non metastatic prostate cancer after radical prostatectomy
Main outcome variables
Basic Prostate specific antigen plasma level ; testosterone and Sex hormone binding globulin plasma level ; Insulin like growth factor_1 plasma level; quality of life ; hepatic transaminases ; serum creatinine ; blood urea nitrogen; side effects especially digestive complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180517039694N1
Registration date:2018-06-13, 1397/03/23
Registration timing:prospective
Last update:2018-06-13, 1397/03/23
Update count:0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Ashkan Fatemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 2082
Email address
fatemisa931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of oral nano formulation of silymarin in non metastatic prostate cancer patients after radical prostatectomy
Public title
Efficacy of oral silymarin formulation on prostate cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intermediate_risk prostate cancer with gleason score<8
Life expectancy more than 10 years
Exclusion criteria:
Patient with history of chemotherapy,radiotherapy or hormone therapy
Patient with chronic liver or kidney or heart disease
Patient with diabetes mellitus
Patient with autoimmune disease
History of hypersensitivity to silymarin
concomitant use of anti inflammatory drugs or other antioxidant
Patient disagreement
Age
From 50 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization based on prepared list by randomization.com site. Then, block randomization of four patients was used to ensure balanced allocation of eligible patients in the control and intervention arms.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Silymarin and placebo nano formulations will fill by producer company and deliver to the oncologist. Patients who fulfilled the inclusion criteria will be selected by oncologist. He will assign them to silymarin or placebo group and give them bottles marked A or B, based on allocation sequence. Evaluation of patients during the chemotherapy course will be performed by the clinical oncologist and pharmacy student. Data collection and analysis will be carried out by the pharmacy student and the clinical pharmacist, respectively. All of them will not aware of the group allocation of the patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
at the beginning of the study, 2 weeks after the beginning of study, one month after the begining of the study , 6 weeks after the beginning of study and at the end of the study
Method of measurement
Serum level measurement by laboratory test
2
Description
testosterone serum level
Timepoint
At the beginning and end of the study
Method of measurement
Serum level measurement by laboratory test
3
Description
Sex hormone binding globulin serum level
Timepoint
At the beginning and the end of the study
Method of measurement
Serum level measurement by laboratory test
4
Description
lnsulin-like growth factor-1 serum level
Timepoint
At the beginning and the end of the study
Method of measurement
Serum level measurement by laboratory test
5
Description
Patient quality of life
Timepoint
At the end of the study
Method of measurement
Expanded Prostate Cancer Index Composite
Secondary outcomes
1
Description
Serum level of hepatic transaminases
Timepoint
At the beginning of the study and after one and two month
Method of measurement
Serum level measurement by laboratory test
2
Description
creatinine Serum level
Timepoint
At the beginning of the study and after one and two month
Method of measurement
Serum level measurement by laboratory test
3
Description
Blood urea nitrogen
Timepoint
AT the beginning of the study and after one and two month
Method of measurement
Serum level measurement by laboratory test
Intervention groups
1
Description
Intervention group: 140mg silymarin/cc four times a day and each time 1cc after meal,oral, for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo for silymarin four times a day and each time 1cc after meal,oral, for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital, affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Street address
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
School of Pharmacy, Ferdosi University Campus, Vakil Abad Blv., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
tafaghodim@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
Ashkan Fatemi Shandiz
Position
Pharm D student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
fatemisa931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh ٍElyasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ashkan Fatemi Shandiz
Position
Pharm D student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdosi University Campus, Vakilabad Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
fatemisa931@mums.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The mentioned data will be published in an article after the completion of the study.
When the data will become available and for how long
The information will be available in article for ever.
To whom data/document is available
any one who want
Under which criteria data/document could be used
Unpublished data will be accessible after agreement of all contributors and also research deputy of Mashhad University of Medical Sciences.
From where data/document is obtainable
Mail to the corresponding author
What processes are involved for a request to access data/document
The request should be discussed with all contributors of the study and research deputy of Mashhad University of Medical Sciences.