Protocol summary

Summary
Background: Gastric cancer is the fourth most common cancer in the world, the second most common cancer in Asia and the second leading cause of death among cancers in the worldwide, that the many factors are involved. Consumption of ω-3 fatty acids supplementation inhibits oxidative stress injury, prevention of cachexia , improve of appetite and reduce of the amount of matrix metaloproteinase enzyme activity in gastric cancer patients. The aim of this study is determination of the effect of ω-3 fatty acids supplementation on nutritional status, some inflammatory factors and matrix metaloproteinase in gastric cancer patients undergoing chemotherapy. Methods: In this study 15 volunteers patients with gastric cancer receiving chemotherapy for cases and 15 volunteers patients for controls are selected by Randomized allocation. Demographic, anthropometric factors, and nutritional information will be collected for patients and changes of weight, BMI, calories and nutrients intake will be calculated for both groups. 3 g of ω-3 fatty acid supplementation for intervention group and placebo for control group will be given for 45 days. Then blood samples in three stages (in the beginning, 30 and 45 days after interval) will be collected to test 2 and 9 matrix metaloproteinases, hepatic acute phase protein, malondialdehyde, tumor necrosis factor-ɑ, interlukin 1, 2 and 6, total antioxidant capacity, blood albumin, serum iron and blood fats.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011095144N1
Registration date: 2011-01-28, 1389/11/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Ali Nemati
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0052
Email address
a.nemati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effect of ω-3 fatty acids supplementation on nutritional status, some inflammatory factors and matrix metalloproteinases in gastric cancer patients undergoing chemotherapy
Public title
Effect of ω-3 fatty acids on gastric cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with gastric cancer in phase 3 (cardia and non cardia) during chemotherapy over 30 years old. Exclusion criteria: other diseases induced cachexia such as heart disease, lung, AIDS, renal disease, incidence of acute leukemia, diabetes and multiple myeloma, individauls undergoing surgery and who do not take the given drugs properly during the study period.
Age
From 30 years old to 100 years old
Gender
Both
Phase
2-3
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
Vice Chancellor of Research in Tabrizl University of medical sciences
Street address
Vice Chancellor of Research, Tabriz University of medical sciences, Daneshgah St.
City
Tabriz
Postal code
Approval date
2010-12-01, 1389/09/10
Ethics committee reference number
1389-09-10

Health conditions studied

1

Description of health condition studied
Gastric cancer patients undergoing chemotherapy
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
weight
Timepoint
days of 0, 30 and 45
Method of measurement
digital scale

Secondary outcomes

1

Description
Body Mass Index
Timepoint
days of 0, 30 and 45
Method of measurement
measured by ratio of weight (kilograms) to squared height (m)

2

Description
daily calorie intake
Timepoint
days of 0, 30 and 45
Method of measurement
24 hour recall questionnaire

3

Description
daily nutreints intake
Timepoint
days of 0, 30 and 45
Method of measurement
24 hour recall questionnaire

4

Description
Nausea
Timepoint
days of 0, 30 and 45
Method of measurement
quaistionnaire

5

Description
Vomiting
Timepoint
days of 0, 30 and 45
Method of measurement
quaistionnaire

6

Description
Appetite
Timepoint
days of 0, 30 and 45
Method of measurement
quaistionnaire

7

Description
dairreha
Timepoint
days of 0, 30 and 45
Method of measurement
quaistionnare

8

Description
abdominal cramp
Timepoint
days of 0, 30 and 45
Method of measurement
quaistionnaire

9

Description
total antioxidant
Timepoint
days of 0, 30 and 45
Method of measurement
spectrophotometry

10

Description
MDA
Timepoint
days of 0, 30 and 45
Method of measurement
spectrophotometry

11

Description
interleukin1
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

12

Description
interleukin 6
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

13

Description
interleukin 2
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

14

Description
TNF-ɑ
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

15

Description
mmp9
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

16

Description
mmp2
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

17

Description
cholestrol
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

18

Description
triglyceride
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

19

Description
TIBC
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

20

Description
Blood albumin
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

21

Description
LDL- C
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

22

Description
HDL-C
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

23

Description
Blood iron
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

24

Description
CRP
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

25

Description
proxonaz 1
Timepoint
days of 0, 30 and 45
Method of measurement
spectophotometry

26

Description
IgA
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

27

Description
IgG
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

28

Description
IgM
Timepoint
days of 0, 30 and 45
Method of measurement
ELISA

29

Description
transferrin
Timepoint
days of 0, 30 and 45
Method of measurement
autoanalyzer

Intervention groups

1

Description
Interventions 1: ω-3 fatty acids, 3 g daily for 45 days
Category
Treatment - Drugs

2

Description
interventions2: rice powder, three capsules daily for 45 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Aras clinic of Imam Hospital
Full name of responsible person
Ali Nemati
Street address
Ardabil University of Medical Sciences
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nutririon research center
Full name of responsible person
Dr. Alireza ostadrahimi
Street address
Nutrition research center, faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st
City
Tabriz
Grant name
1389-10-7
Grant code / Reference number
07-10-1389
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutririon 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
M.Sc. in nutrition
Other areas of specialty/work
Street address
Basic Science group, Faculty of Medicine, Ardebil University of Medical Sciences
City
Ardebil
Postal code
Iran
Phone
+98 45 1551 0052
Fax
+98 45 1551 0057
Email
a.nemati@arums.ac.ir
Web page address
www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
Ph.D Student/ faculty member
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences
City
Ardebi
Postal code
Phone
+98 45 1551 0052
Fax
+98 45 1551 0057
Email
a.nemati@arums.ac.ir
Web page address
www.arums.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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