Investigation of eight weeks aerobic exercise effect on the associated serum microRNAs levels with antiangiogenesis and cell death in prostate cancer patients
Design
The clinical trial has an experimental group (n=10) and a control group (n=10) which it is voluntarily divided into two groups. The experimental group has no sports intervention and the control group do not have any intervention.
Settings and conduct
The list of men aged 55 to 66 years (Tehran city) were selected with benign prostate cancer without metastasis and the referred people to the centers in 1397. Necessary permits were obtained to refer to specialized oncology and urology treatment centers of Tehran University of Medical Sciences, including Shahid Hasheminejad and Sina Hospitals and related clinics. Out of 138 eligible people, 45 people had announced their readiness and finally, 20 people had the necessary conditions. And after obtaining their consents, they exercised with body weight and the above research was done in a sports club under the supervision of a researcher. Blinding has not been done.
Participants/Inclusion and exclusion criteria
Men aged 55 to 66 years old who have the benign cancer in Tehran city without metastasis and physical problems such as orthopedic and cerebral problems, neurological and also, interest in sports and participation in research projects
Intervention groups
Experimental group exercises are three sessions per week for 8 weeks and each training session includes 10 minutes of warm-up with a variety of stretching, flexibility and running and then, continuous running with a constant trend and intensity of 60 to 70% HRR. Also, the control group does not have a regular exercise during these eight weeks and only has daily activities.
Main outcome variables
Serum microRNAs are associated with antiangiogenesis and cell death in prostate cancer patients including miR-15a, miR-16 and miR-329
General information
Reason for update
Acronym
TPCS
IRCT registration information
IRCT registration number:IRCT20200928048866N1
Registration date:2020-10-29, 1399/08/08
Registration timing:retrospective
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Mehdi Garshasbi
Name of organization / entity
Social Security Organization
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
md_garshasb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-01-12, 1398/10/22
Actual recruitment start date
2020-01-10, 1398/10/20
Actual recruitment end date
2020-03-14, 1398/12/24
Trial completion date
2020-03-14, 1398/12/24
Scientific title
The effect of an aerobic exercise course on the associated serum microRNA levels with antiangiogenesis and cell death in prostate cancer patients
Public title
Investigation of aerobic exercise effect on prostate cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining the necessary permits for referring to specialized oncology treatment centers
Failure to do the radiation therapy, chemotherapy and androgen therapy
They have been diagnosed with prostate cancer at least one month ago
Do not smoke or drink alcohol
No physical problems that prevent exercise such as orthopedic, brain problems and nerve
All patients with benign prostate cancer
Exclusion criteria:
Blood pressure> 180/110
Cardiovascular diseases
History of surgery
Family dissatisfaction
Overweight
Age
From 55 years old to 66 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the effect of exercise activities on angiogenesis and anti-angiogenesis factors and microRNA changes has been investigated in cancer patients by monitoring some microRNAs and factors that increase the associated angiogenesis with cancer and it can cause metastasis and resistance to chemotherapy and other treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University
Street address
Unit 4, No. 22, , Banafsheh Alley, Jihad Akbar St., Sattari Highway Mojahed Kabir St., West Laleh Blvd
City
Tehran
Province
Tehran
Postal code
1473993374
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.QOM.REC.1398.021
Health conditions studied
1
Description of health condition studied
The role of exercise and microRNAs in prostate cancer
ICD-10 code
C60-c63
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
The percentage of people with decreasing the serum mirRNA-15a
Timepoint
Pre and post-test
Method of measurement
Blood test (RNA extraction kit for Riz biofanavaran company. And also, RT steam-loop house keeping method was used to check microRNA levels)
Secondary outcomes
1
Description
The percentage of people with decreasing the serum mirRNA-329
Timepoint
Pre and post-test
Method of measurement
Blood test (RNA extraction kit rena biotechnology company. And also, RT steam-loop house keeping method was used to check microRNA levels)
2
Description
The percentage of people with decreasing the serum mirRNA-16-1
Timepoint
Pre and post-test
Method of measurement
Blood test (RNA extraction kit rena biotechnology company. And also, RT steam-loop house keeping method was used to check microRNA levels)
Intervention groups
1
Description
Intervention group: Resistance training consisted includes eight weeks and 3 sessions per week. The program includes a 10-minute warm-up session with a various of stretching, flexibility and running exercises. Then, continuous running with a constant trend and intensity of 60 to 70% of HRR (Carvonen formula) was performed using a pulse gauge belt. The duration of running was 15 minutes in the first session and one minute was added to each session in the running time. The maximum heart rate was calculated from the formula age-220. At the end of each session, the cooling operation will be achieved by performing soft running, stretching and soft movements for ten minutes.
Category
Treatment - Other
2
Description
Control group: without treatment and participate in exercise. It plays important role in the experimental process
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminejad Hospital
Full name of responsible person
Mehdi garshasbi
Street address
Shahid Valinejad Alley, Vanak Square
City
Tehran
Province
Tehran
Postal code
1471319697
Phone
+98 21 81161
Fax
+98 21 4486 5383
Email
info@medicalnet.ir
Web page address
https://www.instagram.com/Hasheminejad.tums/
2
Recruitment center
Name of recruitment center
Sinai Hospital
Full name of responsible person
Mehdi garshasbi
Street address
Hassanabad Square, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1471319697
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
info@medicalnet.ir
Web page address
https://www.instagram.com/sina.tums/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi garshasbi
Street address
shodada Hesarak blvd, Daneshgah Square, Sattari
City
Tehran
Province
Tehran
Postal code
1473993374
Phone
+98 21 4447 2341
Email
md_garshasb@yahoo.com
Web page address
http://fa.irct.ir/
Grant name
no
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, University of Research 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
Islamic Azad University
Full name of responsible person
Mehdi garshasbi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
NO 22, Banafsheh 3 Ave, South Star Highway
City
Tehran
Province
Tehran
Postal code
1473993374
Phone
+98 21 4447 2341
Email
md_garshasb@yahoo.com
Web page address
http://fa.irct.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hussein Abed Natanzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Science and Research Branch, Islamic Azad University، Shohada Hesarak Blv, University Square, End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Fax
Email
abednazari@gmail.com
Web page address
http://std.srbiau.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi garshasbi
Position
ph.D student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No 22, Banafseh Alley, Mojahed Kabir St, West Laleh Blvd,Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893755
Phone
+98 21 4447 2341
Email
md_garshasb@yahoo.com
Web page address
http://fa.irct.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Failure to complete information in this issue
Study Protocol
No - There is not 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