Protocol summary

Study aim
Comparison of clinical status and immune responses of patients with colon cancer under standard treatment with patients receiving Byolic CC along with standard treatment
Design
The phase 3 Clinical trial with a control group, with parallel groups, double-blind, randomized, on 70 patients.
Settings and conduct
70 patients with colon cancer were randomly divided into 2 groups of 35 people and they took medicine or placebo once a day along with standard treatment for 2 months. • Group 1: Byolic CC capsules produced by Behpad Tab along with standard treatment • Group 2: use of placebo capsules produced by Behpad Teb company along with standard treatment The study site is Shahid Mustafa Khomeini Hospital. Neither the patient nor the doctor knows the nature of the drug and the placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of colon cancer in colonoscopy with histopathological examination No history of inflammatory bowel diseases exclusion criteria: Necessity of surgery or emergency operation or radiotherapy Active infection Other systemic immune disorders
Intervention groups
Intervention group: Patients with colon cancer receive Byolic CC capsules produced by Behpad Tab Company for 2 months, once a day, preferably with a meal along with their standard treatment. Placebo group: Patients with colon cancer receive placebo capsules for 2 months, once a day, preferably with a meal along with their standard treatment.
Main outcome variables
Karnofski performance scale index CEA index of colon cancer patients The number of T CD4 and T CD3 CD8 cells in patients with colon cancer Serum concentration of regulatory (IL-10 - TGF-β) and inflammatory (TNF, IL-6) cytokines in colon cancer patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240304061158N3
Registration date: 2024-07-25, 1403/05/04
Registration timing: registered_while_recruiting

Last update: 2024-07-25, 1403/05/04
Update count: 0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
fariba nemati
Name of organization / entity
Behpad Teb Iranian
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6890
Email address
info@behpadti.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical status and immune responses of patients with colon cancer under standard treatment with patients receiving a product containing the herbal immunomodulator Byolic CC along with standard treatment
Public title
Investigating the effect of Byolic CC product consumption along with standard treatment in patients with colon cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of colon cancer in colonoscopy with histopathological examination
Exclusion criteria:
Necessity of surgery or emergency operation or radiotherapy Active infection Systemic immune disorders history of inflammatory bowel diseases pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the eligible patients, the patients will be randomized into 2 groups using the randomization method based on random blocks. In this way, 2 blocks are formed by combining codes A and B, related to the intervention and control groups. Then the blocks will be randomly selected based on the rand function from the Excel software until the final volume of the sample is reached. Grouping is done by determining 70 non-transparent envelopes that have the group number on the envelope and the type of intervention inside the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Byolic CC supplement and placebo are both provided to the researcher in the same and coded packaging.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran (routing)
City
tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-08-24, 1402/06/02
Ethics committee reference number
IR.SHAHED.REC.1402.076

Health conditions studied

1

Description of health condition studied
colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon

Primary outcomes

1

Description
Karnofsky performance scale index
Timepoint
The Karnofsky index will be calculated on day zero at the beginning of the study and day 60 at the end of the study.
Method of measurement
The Karnofsky index is measured using physical examination checklist.

Secondary outcomes

1

Description
CEA index of colon cancer patients
Timepoint
The CEA index will be assessed on day zero at the beginning of the study and on day 60 at the end of the study.
Method of measurement
The CEA index is calculated using a clinical examination checklist.

2

Description
Counting of T CD3 CD8 and T CD4 cells
Timepoint
Counting of T CD8 CD3 and T CD4 cells will be done on day zero at the beginning of the study and on day 60 at the end of the study.
Method of measurement
Counting of T CD8 CD3 and T CD4 cells will be done using flow cytometry.

3

Description
Regulatory and inflammatory cytokines assay
Timepoint
Cytokines will be measured on day zero at the beginning of the study and day 60 at the end of the study.
Method of measurement
Cytokines IL-10, TGF-β, TNF, IL-6 will be measured using ELISA technique.

4

Description
Cell cycle checkpoints mRNA expression
Timepoint
The expression of cell cycle checkpoint genes is measured on day 0 at the beginning of the study and on day 60 at the end of the study.
Method of measurement
Gene expression measurement of cell cycle checkpoints (CTLA-4, PD-1) is performed by Real-time PCR technique.

Intervention groups

1

Description
Intervention group: Patients with colon cancer receive Byolic CC capsules produced by Behpad Tab for 2 months, once a day, preferably with meals along with their standard treatment.
Category
Treatment - Other

2

Description
Control group: Patients with colon cancer receive pelacebo capsules produced by Behpad Tab for 2 months, once a day, preferably with meals along with their standard treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
rahimlou bahman
Street address
No. 9, Italy St., Palestine St., Keshavarz Boulevard, Valiasr Square, Tehran
City
tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8897 5477
Fax
+98 21 8896 3739
Email
info@mkht.ir
Web page address
http://mkht.ir/en

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behpad Teb Iranian
Full name of responsible person
Fariba Nemati
Street address
Tehran, 20th km of Damavand Road, Pardis Technology Park, Danesh 4, Fanavaran Bldg, Unit 22
City
tehran
Province
Tehran
Postal code
1654120611
Phone
+98 21 6642 6890
Fax
+98 21 4066 0468
Email
info@behpadti.com
Web page address
https://behpadti.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behpad Teb Iranian
Proportion provided by this source
50
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
Industry

2

Sponsor
Name of organization / entity
Shahed university Immune Response Regulation Research Center
Full name of responsible person
bahman rahimlou
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
immunoreg@shahed.ac.ir
Web page address
https://irrc.shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed university Immune Response Regulation Research Center
Proportion provided by this source
49
Public or private sector
Public
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
Immunoregulation Research Center
Full name of responsible person
rahimlou bahman
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
bahman.rahimloo.73@gmail.com
Web page address
https://irrc.shahed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mostafa Khomeini Hospita
Full name of responsible person
Dr. Jalaluddin Shams
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
hematologist oncologist
Street address
9, Italy St Palestine St- Keshavarz Boulevard – Valiasr Square – Tehran
City
tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 6130
Fax
+98 21 8896 3739
Email
jalalshams@yahoo.com
Web page address
http://mkht.ir/en/

Person responsible for updating data

Contact
Name of organization / entity
Immunoregulation Research Center
Full name of responsible person
Azade Rashidi
Position
master of science
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6641 9712
Fax
+98 21 6641 9752
Email
a.rashidi@shahed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Ethical consideration about patient information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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