Evaluation of the effect of polyunsaturated fatty acids on the level of genes and Proteins of MMP1 , MMP9 , PDCD4 in gastric mucosal tissue in patients with gastric adenocarsinoma under chemotherapy
This study aimed to Evaluate the effect of oral administration polyunsaturated fatty acids on oxidative stress in patients with 9gastric cancer will be done, the main goal of this study decrease of drug resistance in this patients. The patients of the Endoscopy Clinic of Tabriz University of Medical Sciences with a presumptive diagnosis of gastric tumor will sample 3 biopsy of the gastric tumor was removed and immediately transferred to liquid nitrogen tank will be . 34 patients in the two group of 17 people with written consent and with full knowledge of the research topic. In two groups, the first group of selective chemotherapy with no chemotherapy group Bamkml supplements and omega-3 fatty acids , Omega 6 and Omega-9 3000 mg daily dose for 3 months will start . After 3 months again from the biopsy samples taken from the patient immediately transferred to the nitrogen tank to be tested will be transferred to the relevant department . Experiment is performed on biopsy specimens.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121216922N2
Registration date:2017-01-24, 1395/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Homayun Dolatkhah
Name of organization / entity
Dept. of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 1775 3824
Email address
dolatkhahh@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz liver and Gastrointestinal Disease research center
Expected recruitment start date
2015-07-15, 1394/04/24
Expected recruitment end date
2016-07-28, 1395/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of polyunsaturated fatty acids on the level of genes and Proteins of MMP1 , MMP9 , PDCD4 in gastric mucosal tissue in patients with gastric adenocarsinoma under chemotherapy
Public title
Effect of Omega Fatty Acids on treatment of Gastric Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with gastric adenocarcinoma who that the chemotherapy will be. Exclusion criteria: People who are not taking medication due to cardiac obstruction; Pyloric obstruction due to people who are not able to take medicine; Diabetic patients; Patients with renal failure; Three months before entering the study, patients who are taking omega supplements.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
34
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
tabriz university of medical science
Street address
faculty of medicine ,tabriz university of medical science,golgasht ave,tabriz,I.R.IRAN
City
Tabriz
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.TBZMED.REC.1395.677
Health conditions studied
1
Description of health condition studied
Gastric Adenocarsinoma
ICD-10 code
c16.2
ICD-10 code description
Malignant neoplasm of body of stomach
Primary outcomes
1
Description
drug resistance
Timepoint
before and after
Method of measurement
jen expression and level of protein
Secondary outcomes
1
Description
oxidative stress
Timepoint
before and after
Method of measurement
jen expression and level of protein
Intervention groups
1
Description
The second group oxaliplatin drug with pills Natural Factors Ultimate-Omega Factors 1200 mg of omega-3 fatty acid, omega-6 and Omega-9 to the formula: Fish Oil Blend 400 mg, Flexseed Oil 400 mg, Borage Oil 400 mg, daily the amount of 3600 mg for 3 courses including a three-week period, the treated. After this time the biopsy was done and the tumor treatment will follow.
Category
Treatment - Drugs
2
Description
In two groups to,The first group of patients was treated with oxaloplatin without prescription of omega fatty acids for three course, and each course includes three weeks .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza Hospital
Full name of responsible person
mehran khojastefard
Street address
Emam reza Hospital,golgasht Ave,tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz liver and Gastrointestinal Disease research Center
Full name of responsible person
Prof. Dr. Mohammad-Hosein Somi
Street address
Emam Reza Hospital, Daneshgah Str.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz liver and Gastrointestinal Disease research Center
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
Faculty of Medicin, Tabriz University
Full name of responsible person
Mehran Khojastefard
Position
Msc ,Clinical Biochemistry
Other areas of specialty/work
Street address
Faculty of Medicin, Tabriz University of Medical Science, Golgasht Ave, Tabriz, I.R.IRAN