Backgrounds and Objectives:some blood factors and biochemical indices can cause occurrence and recurrence of breast cancer. On the other hand, the role of combination exercise training on these factors is not clear. Thus, the aim of this study is to clarify the changes of these factors in postmenopausal women with breast cancer after 15 weeks combination exercise training. Design, setting and conduction: Twenty nine women with breast cancer (58.27 ± 6.31 years) who received surgery, chemotherapy and radiation - therapy with current hormone therapy were divided into two groups; experimental and control (Double-blind randomised clinical trial). Participants including major eligibility criteria: Inclusion criteria included being postmenopausal, Tamoxifen consumption, inactivity and lack of other diseases. Intervention: Subjects of experimental group were performed 15 weeks combination exercise training including walking (2 sessions per week) and resistance training (2 sessions per week that different from walking days). Variables: in this study, IGFs and its Binding proteins, Some Antioxidants, Sex hormones and inflammation factors were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122115884N1
Registration date:2014-05-05, 1393/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Reza Nuri
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 76 4443 0055
Email address
nuri_r7@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2008-06-21, 1387/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of combination exercise training on some blood factors and biochemical indices in women with breast cancer
Public title
Cancer and combination exercise training
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - the current treatments and undergoing hormone therapy with tamoxifen; 2 menopause ; 3- age 50 to 60 years.
exclusion criteria : 1-participating in sports or physical activity and weight control in six months; 2 - Other diseases, such as hypertension, heart disease, and thyroid; 3 - Use Supplement; 4 - The experience of menstruation in the past six months.
Age
From 50 years old to 69 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Sport Physiology, University of Guilan
Street address
Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan
City
Rasht
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
12/1243
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.6
ICD-10 code description
Axillary tail of breast
Primary outcomes
1
Description
Insulin like growth factors
Timepoint
pre and after intervention
Method of measurement
In serum using by EKM
2
Description
estradiol
Timepoint
pre and after intervention
Method of measurement
In plasma using by ELISA kits
3
Description
Progestron
Timepoint
pre and after intervention
Method of measurement
In plasma using byELISA kits
4
Description
Metabolic syndrome
Timepoint
pre and after intervention
Method of measurement
By current measurements methods
5
Description
Glutation proxidase
Timepoint
pre and after intervention
Method of measurement
In serum using by EKM kits
6
Description
Super oxide dismutase
Timepoint
pre and after intervention
Method of measurement
In serum using by EKM kits
Secondary outcomes
1
Description
Some IGFs binding Proteins
Timepoint
pre and after intervention
Method of measurement
In serum using by ELISA kits
Intervention groups
1
Description
15 weeks combination exercise training including resistance training and walking for exprimental group
Category
Other
2
Description
current therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Seyodoshohada Hospital
Full name of responsible person
Dr Hamid Emami
Street address
Department of Oncology, Seyodoshohada Hospital, Motahari ave. Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Guilan
Full name of responsible person
Street address
Vice chancellor for research, University Of Guilan, Faculty of Sport Sciences, 7th km of Tehran Road, Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Guilan
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
University of Guilan
Full name of responsible person
Farhad Rahmani-Nia
Position
Ph.D/ Professor in Exercise Physiology.
Other areas of specialty/work
Street address
Vice chancellor for research, Faculty of Sport Sciences, 7th km Of Tehran Road, Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 1669 0685
Fax
Email
frahmani2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Nuri
Position
Ph.D
Other areas of specialty/work
Street address
Kish International Campus, Mirmohanna Blv, Naiyesh Avenue, Kish, Iran
City
Kish
Postal code
Phone
+98 76 4443 0055
Fax
Email
nuri_r7@ut.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran, Kish Internation Campus
Full name of responsible person
Reza Nuri
Position
Ph.D/ Assistant Professor
Other areas of specialty/work
Street address
Department of Sport Sciences, Kish International Campus, Niayesh Avenue, Mirmohanna Blv, Kish Island, Iran
City
Kish
Postal code
Phone
+98 76 4443 0056
Fax
Email
nuri_r7@ut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)