Protocol summary

Summary
Main goal: Evaluation the efficacy of polyamine-deprived dietary regimen on Angiogenic growth factors and Tumor markers in patients with Lung cancer, Inclusion Criteria: age between 30 to 70; healthy function of liver and kidney; lung cancer diagnosis Exclusion Criteria: Chemotherapy; Food supplement or other dietary regimen; diabetes patients. Patients with lung cancer betwwen 30 to 70 which referred to Shafa Hospital under supervision of Oncologist will recruit in this study.Sample size in each group will be 30. All of them befor chemotherapy devided in two groups and then under the supervision of dietition will be under specefic regimen with low level of polyamine and for inhibition of intestinal production of polyamine give Neomycin. 5 cc blood from all participant will obtain and blood keep in -30 C until analysis, for analyzing following parameters : Hepatic Growth Factor, Eidermal Growth Factor Receptor, Matrix MetalloProteinase 1, TIMP Metallopeptidase Inhibitor 1, Plasminogen Activator Inhibitor 1, urokinase (uPA)-mediated plasminogen activation, Vascular cell adhesion protein 1, Intercellular Adhesion Molecule 1, and tumor markers including Squamous Cell Carcinoma, Carcinoembryonic antigen Cyfra-21and also Interleukin -10 Interleukin 2

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020626390N1
Registration date: 2016-06-18, 1395/03/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Ehsan Ghaedi
Name of organization / entity
Ahwaz Jundishapoor ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3285
Email address
ghaedi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapoor University of Medical Sceinces
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of polyamine-deprived dietary regimen on Angiogenic growth factors and Tumor markers in patients with Lung cancer
Public title
Evaluation the efficacy of polyamine-deprived dietary regimen Lung cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: age between 30 to 70; healthy function of liver and kidney; lung cancer diagnosis Exclusion Criteria: Chemotherapy; Food supplement or other dietary regimen; diabetes patients
Age
From 16 years old to 88 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz jondishapoor uneversity of medical sciences
Street address
a
City
ahwaz
Postal code
.
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.590

Health conditions studied

1

Description of health condition studied
lung cancer
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung

Primary outcomes

1

Description
Hepatic Growth Factor
Timepoint
befor and after
Method of measurement
Labaratory Kits,

2

Description
Eidermal Growth Factor Receptor
Timepoint
befor and after
Method of measurement
Labaratory Kits,

3

Description
Matrix MetalloProteinase 2
Timepoint
befor and after
Method of measurement
Labaratory Kits,

4

Description
TIMP Metallopeptidase Inhibitor 1
Timepoint
befor and after
Method of measurement
Labaratory Kits,

5

Description
Plasminogen Activator Inhibitor 1
Timepoint
befor and after
Method of measurement
Labaratory Kits,

6

Description
urokinase (uPA)-mediated plasminogen activation
Timepoint
befor and after
Method of measurement
Labaratory Kits,

7

Description
Vascular cell adhesion protein 1
Timepoint
befor and after
Method of measurement
Labaratory Kits,

8

Description
Intercellular Adhesion Molecule 1
Timepoint
befor and after
Method of measurement
Labaratory Kits,

9

Description
Squamous Cell Carcinoma
Timepoint
befor and after
Method of measurement
Labaratory Kits,

10

Description
Carcinoembryonic antigen
Timepoint
befor and after
Method of measurement
Labaratory Kits,

11

Description
Cyfra-21
Timepoint
befor and after
Method of measurement
Labaratory Kits,

12

Description
Interleukin -10
Timepoint
befor and after
Method of measurement
Labaratory Kits,

13

Description
Interleukin 2
Timepoint
befor and after
Method of measurement
Labaratory Kits,

Secondary outcomes

1

Description
weight
Timepoint
befor and after
Method of measurement
kg

Intervention groups

1

Description
Patients will experience poly amine restricted diet under supervision of of dietition for 6 month intervention group
Category
Treatment - Other

2

Description
In control group by the Adjusted Ideal Body weight will be under supervision of Dietition,
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
ShAfa Hospital
Full name of responsible person
Dr. Ahmadzade, Oncologist
Street address
Shafa Hospital, Farvardin Street, Golestan Bolvard, Ahwaz
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Science
Full name of responsible person
Nader Saaki
Street address
Ahwaz
City
Ahwaz
Grant name
.
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Science
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
Ahwaz Jundishapoor University of Medical Science
Full name of responsible person
Ahmad Ahmadzadeh
Position
Oncologist
Other areas of specialty/work
Street address
Shafa Hospital, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
m_pedram@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hemoglubinopathy Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Hemoglobinopathy Center, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
en7cyrus@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Haemoglubinopathy Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Haemoglubinopathy Centerو Shafa Hospital, Ahwaz
City
Ahwaz
Postal code
6135733119
Phone
+98 61 3374 3285
Fax
+98 61 3374 3289
Email
Web page address
http://hshafa.ajums.ac.ir/

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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