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,