The aim of this study is investigating of the effectiveness of metformin on radiation protection in patients with prostate cancer during treatment with radiotherapy.
Design
In this double-blind randomized controlled clinical trial with parallel group, sixty (60) patients will be allocated in one of two groups and received metformin or placebo, with blocked randomization method.
Settings and conduct
Patients referring to Department of Radiotherapy, Golestan Hospital, Ahvaz suffering from non-metastatic prostate cancer will be allocated in one of two groups based on blocked randomization. The intervention group receives metformin tablet at a dose of 1000 mg orally once a day and control group receive placebo orally once a day at day 0 (before starting radiation therapy) until one month after the final session of radiotherapy. Physicians and patients do not know if patients are receiving drug or placebo. The radiation protection effects will be measured by the level of antioxidant enzymes including superoxide dismutase, catalase, glutathione peroxidase and total antioxidant capacity in patients plasma in day 0, 14, 28, 42 and 56 during radiotherapy course and one month after the final session of radiotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with localized prostate cancers that undergo definitive or postoperative external radiotherapy. Exclusion criteria: Metastasis; Renal or hepatic dysfunction; Cardiovascular failure; Severe respiratory disorders; Severe hematological disorders; Diabetic patients; Metformin allergy.
Intervention groups
The intervention group receive metformin tablet at a dose of 1000 mg orally once a day and control group receive placebo orally once a day.
Main outcome variables
The radiation protection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032933N3
Registration date:2018-10-22, 1397/07/30
Registration timing:prospective
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Pedram Nazari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 7705
Email address
nazari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigating of Radiation Protection Effects of Metformin in Patients with Prostate Cancer Treated with Radiotherapy
Public title
Radiation Protection Effects of Metformin in Prostate Cancer
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with localized prostate cancers that undergo definitive or postoperative external radiotherapy
Exclusion criteria:
Patients with metastatic prostate cancer
Patients previously treated with radiotherapy or chemotherapy
Patients with renal or liver dysfunction
Patients with severe respiratory diseases (such as obstructive pulmonary disorders or severe asthma)
Patients with hematological disorders (such as severe anemia or vitamin B12 deficiency)
Diabetic patients
Smoker patients
Metformin hypersensitivity
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control will be done by Block Balanced Randomization (BBR) method. The Randomization Sequence will be generated with using the free website at http://www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The patients know they are participating in an investigation that is aimed to evaluate the metformin effect on prostate cancer but they are not informed that they receive placebo or metformin. The physician who evaluates the clinical status of patients and the nurse who prescribe the drug are not aware of the medication that patients receive. Medications are similar in appearance, color, smell and taste.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.AJUMS.REC.1397.451
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Radiation protection effect
Timepoint
At 0, every two weeks during radiotherapy course and one month after the final session of radiotherapy.
Method of measurement
Oxidative stress tests
Secondary outcomes
1
Description
Urogenital complications
Timepoint
At 0, every two weeks during radiotherapy course and one month after the final session of radiotherapy.
Method of measurement
Toxicity Criteria of the Radiation Therapy Oncology Group
Intervention groups
1
Description
Intervention group: Metformin tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy
Category
Prevention
2
Description
Control group: Placebo tablet at a dose of 1000 mg orally once a day will be prescribed before starting radiation therapy by one month after the final session of radiotherapy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Pedram Nazari
Street address
Golestan Hospital, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3292 1837
Email
dr.pedramnazari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Golestan Bolvard, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 4355 4063
Email
dr.pedramnazari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sasan Razmjoo
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
razmjoo-s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohsen Cheki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
mohsencheky@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pedram Nazari
Position
Research Assistance
Latest degree
Medical doctor
Other areas of specialty/work
Oncology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 910 209 2933
Fax
+98 61 4355 4063
Email
nazari.p@ajums.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