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Exercise training effects on improving resistance to chemotherapy in patients with breast and gastrointestinal cancer: Randomize phase II clinical trail

Protocol summary

Summary
According to increased drug resistance and high prevalence of cancer, a lot of studies have been performed in developed countries for improving the quality of life and enhancing the survival rate in patient. Among these, attention to physical activity and exercise training have been very important and have attracted many advocates. Therefore, the present randomized trial study will be aimed to investigate the role of the interval exercise training on improving of the parameters involved in chemotherapy resistance in treatment-resistant breast and gastrointestinal cancer patients. Subjects include 60 female patients with breast and gastrointestinal cancer between the ages of 30 to 60 years, referred to Cancer Institute of Iran since September 2016 to September 2017 which randomly divides into two groups: the exercise training with standard treatment group and without the exercise training group. The exercise training duration is 13 weeks, and before the start of training protocol and 48 hours after the last exercise session. Serum samples from patients are collected before and after the exercise training and stored at -80 °C until measurement time. Evaluations include the Vo2 max measurement, the life quality survey, and assay to p-gp, ABC, P53, P63, P68, BRCA1 and BRCA2, topoisomerase I and II, Her2, and metallothionein, glutathione and superoxide dismutase using conventional ELISA, Western blot and immunohistochemistry methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041818745N7
Registration date: 2016-06-30, 1395/04/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences and Golestan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exercise training effects on improving resistance to chemotherapy in patients with breast and gastrointestinal cancer: Randomize phase II clinical trail
Public title
Exercise training effects on improving resistance to chemotherapy in patients with breast and gastrointestinal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consist: 30-60 year-old women with breast and gastrointestinal cancers; detection of the disease during years 94 and 95; during chemotherapy; by obtaining written consent; lack of response to at least one chemotherapy period (treatment response less than 50%; local recurrence of the disease; the ability of doing exercise training. Exclusion criteria consist: the lack of cardiovascular disease; out of control blood pressure; diabetes; mental illness; infection or immune and endocrine diseases; metastatic disease.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway,Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.IUMS.REC.1394.25629

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

2

Description of health condition studied
colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon

Primary outcomes

1

Description
Response to treatment
Timepoint
Destroy of tumor or decrease of tumor size
Method of measurement
CT or MRI

Secondary outcomes

1

Description
Vo2 max , quality of life , and p-gp, ABC, P53, P63, P68, BRCA1 and BRCA2, topoisomerase I and II, Her2, and metallothionein, glutathione and superoxide dismutase
Timepoint
before and after the exercise training
Method of measurement
Questionnaire- Patient records- Blood samples- Western blotting- ELISA- Immunohistochemistry- gene expression

Intervention groups

1

Description
2- The second group receives only the standard treatments.
Category
Treatment - Drugs

2

Description
1- The first group receives exercise training with the standard treatments (13 weeks, 3 sessions per week, each session 60-90 min)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Research Center, Cancer Institute of IR. Iran, Imam Khomeini Hospital
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University In Tehran, Iran
Full name of responsible person
Dr. Mousavi
Street address
Fifth Floor, Iran University of Medical Sciences Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University In Tehran, Iran
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Golestan University Of Medical Sciences
Full name of responsible person
Dr. Khosh Niyat
Street address
Central Organization of Golestan University of Medical Sciences, Iran Hyrkan, Gorgan, Golestan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University Of Medical Sciences
Proportion provided by this source
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
Cancer Research Center, Cancer Institute of IR. Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of IR. Iran
Full name of responsible person
Dr Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Person responsible for updating data

Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of IR. Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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