Protocol summary

Summary
Main goal: evaluation the efficacy of Ubiquinon on Angiogenic growth factors in patients with Gastric cancer. Inclusion criteria: age between 25 to 75 years old; healthy function of liver and kidney; gastric cancer diagnosis. Exclusion criteria: chemotherapy; food supplement or other dietary regimen; diabetes mellitus. Patients with gastric cancer who referred to Shafa hospital under supervision of oncologist will be recruited in this study. Sample size in each group will be 30. All of them before chemotherapy are divided in two groups and then under the supervision of dietitian will be under supplementation with 200 mg Coenzyme Q10. 5 cc blood from all participant will obtain and blood keep in -30 C until analysis, for analyzing following parameters: Hepatic Growth Factor, Matrix MetalloProteinase 2, Plasminogen Activator Inhibitor 1, Vascular cell adhesion protein 1, Transforming Growth Factor-B, Basic Fibroblast Growth Factor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100426390N2
Registration date: 2016-10-22, 1395/08/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-22, 1395/08/01
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 Jundishapour University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Ubiquinon on Angiogenic growth factors in patients with gastric cancer
Public title
Effect of Coenzyme Q10 on Gastric cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 25 to 75 years old; healthy function of liver and kidney; gastric cancer diagnosis. Exclusion criteria: chemotherapy; food supplement or other dietary regimen; diabetes mellitus.
Age
From 25 years old to 75 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
Not 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
Ahwaz, Golestan Blvd, AJUMS
City
Ahwaz
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.AJUMS.REC.1395.81

Health conditions studied

1

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

Primary outcomes

1

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

2

Description
Matrix Metalloproteinase 2
Timepoint
before and after intervention
Method of measurement
Labaratory Kits,

3

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

4

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

5

Description
Transforming Growth Factor beta
Timepoint
before and after intervention
Method of measurement
Labaratory Kits,

6

Description
Basic Fibroblastic Growth Factor
Timepoint
before and after intervention
Method of measurement
Labaratory Kits,

Secondary outcomes

1

Description
Weight
Timepoint
before and after intervention
Method of measurement
Scale

Intervention groups

1

Description
Patients will experience CoenzymeQ10 200 mg supplementation under supervision of dietition for 3 month intervention group
Category
Treatment - Drugs

2

Description
Patients in control group will take placebo in the same number as intervention group for 3 month.
Category
Treatment - Drugs

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
Sharif Makhmalzadeh
Street address
Ahwaz, AJums
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
crc@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Cancer research Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Cancer research Center,Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
crc@ajums.ac.ir
Web page address

Person responsible for updating data

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

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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