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
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.