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Offering a nutritional formula by enriched soup (extra useful) with anti-inflammatory and immunity booster with optimal taste in advanced local gastrointestinal cancer Patients

Protocol summary

Study aim
Offering a nutritional formula by enriched soup with anti-inflammatory and immunity booster with optimal taste in advanced local gastrointestinal cancer Patients
Design
A randomized, triple blinded, Clinical trial with a parallel group design of 50 patients, enrolled between October 2019 and October 2020.
Settings and conduct
Patients with advanced local gastrointestinal cancer refereeing to cancer research center of SBMU in 2019-2020 At the beginning of the study, half of the treatment and on the last day of treatment, 10 cc blood samples will be taken from patients to control inflammatory and peroxidase factors. The project consisted of three stages: Step One: Provide a formulation of a beneficial nutrient. Step Two: Preparation of the desired food with a formulation that is generally acceptable to the patient for a food that will be prepared by the professors of the Food Industry Institute of Nutrition Research and the Faculty of Nutrition Sciences and Food Technology. Stage Three: Study the effects of prepared foods in a tripple blind clinical trial. After preparing of the mentioned food, the food will be used in low volume and after approval of quality, quantity and taste test. Eliza kits will be used to control IL1- IL6-TNFa and metallo peroxidase. Liver - Lipid Profile - CBC tests will be studied in the studied samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with advanced local gastrointestinal cancer Without any age limitation Exclusion criteria: Patients with other cancers
Intervention groups
Patients with advanced local gastrointestinal cancer
Main outcome variables
Double-acting food ", " standard diet", "Metalo peroxidase", "IL1", "IL6", "TNFa", "Quality of Life", "Complications", "Albumin", "Lymphocytes", "BMI", "MDA", "mir-638", "Protein Carbonylated PrC", "8-ohdg", " oxidan-Antioxidant (PAB)"

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190907044716N1
Registration date: 2019-11-28, 1398/09/07
Registration timing: registered_while_recruiting

Last update: 2019-11-28, 1398/09/07
Update count: 0
Registration date
2019-11-28, 1398/09/07
Registrant information
Name
Ahmad Javanmard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9924
Email address
ajm93dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Offering a nutritional formula by enriched soup (extra useful) with anti-inflammatory and immunity booster with optimal taste in advanced local gastrointestinal cancer Patients
Public title
Offering a nutritional formula by enriched soup
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with advanced local gastrointestinal cancer
Exclusion criteria:
Patients with other cancers
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 3
At the beginning of the study, half of the treatment and on the last day of treatment, 10 cc blood samples will be taken from patients to control inflammatory and peroxidase factors.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, main researcher, health and treatment personals which had responsibility for nutrition will be study by triple blind method. Only data gathering responsible and how evaluate outcome are aware from intervention simultaneous necessary codes belong to patients and at the end collected data will be analysis by main researcher and after final analysis defined codes will be access by main researcher.
Placebo
Not used
Assignment
Parallel
Other design features
This study will have been done by researcher at the first time in Iran on Patients with advanced local gastrointestinal cancer .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Silences
Street address
Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SBMU.REC.1398.022

Health conditions studied

1

Description of health condition studied
Advanced local gastrointestinal cancer
ICD-10 code
C26.9
ICD-10 code description
Malignant neoplasm of ill-defined sites within the digestive system

Primary outcomes

1

Description
Metalo peroxidase
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

2

Description
IL1
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

3

Description
IL6
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

4

Description
Tumor necrosis factor alpha (TNFa)
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

5

Description
Quality of Life
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Based on SF36 test

6

Description
Albumin
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Based on the calorimetric test

7

Description
Lymphocytes
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Based on flow cytometry kit

8

Description
Body mass index
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Weight in kg / squared the person's height in meters ( kg/m2)

9

Description
MDA
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

10

Description
mir-638
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Real-Time Polymerase Chain Reaction

11

Description
Protein Carbonylated PrC
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Bradford test

12

Description
8-ohdg
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa Test

13

Description
oxidant-Antioxidant (PAB)
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Elisa test

Secondary outcomes

1

Description
Quality of Life
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Based on SF36 test

2

Description
Complications
Timepoint
At the beginning of the study, half of the treatment and on the last day of treatment
Method of measurement
Nutrition and Digestive Counseling

Intervention groups

1

Description
Intervention group: Patients with advanced local gastrointestinal cancer. Step One: Provide a formulation of a beneficial nutrient.Step Two: Preparation of the desired food with a formulation that is generally acceptable to the patient for a food that will be prepared by the professors of the Food Industry Institute of Nutrition Research and the Faculty of Nutrition Sciences and Food Technology. Stage Three: Study the effects of prepared foods in a triple blind clinical trial. After preparing of the mentioned food, the food will be used in low volume and after approval of quality, quantity and taste test. Eliza kits will be used to control IL1- IL6-TNFa and metallo peroxidase. Liver - Lipid Profile - CBC tests will be studied in the studied samples.
Category
Treatment - Other

2

Description
Control group: Patients with advanced local gastrointestinal cancer. Step One: Routine Soup which is similar to desired food of Intervention group would be used by control groups. Step Two: Eliza kits will be used to control IL1- IL6-TNFa and metallo peroxidase. Liver - Lipid Profile - CBC tests will be studied in control group as well.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Javanmard
Street address
Cancer Research Center, Tajrish Square., Shohada Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 8001
Fax
+98 21 2274 8001
Email
‍crc@sbmu.ac.ir
Web page address
https://crc.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Javanmard
Street address
Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
National Foundation for Charity Cancer Control
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Javanmard
Position
Phd by research
Latest degree
Ph.D.
Other areas of specialty/work
Cancer and Nutrition
Street address
Fist Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-63113
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9924
Fax
Email
ajm93dr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Javanmard
Position
PhD by research student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
First Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9924
Email
ajm93dr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Javanmard
Position
Phd by research
Latest degree
Ph.D.
Other areas of specialty/work
Cancer and Nutrition
Street address
Fist Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-63113
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9924
Fax
Email
ajm93dr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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