Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer: A triple blinded, randomized clinical trial
Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer
Design
Clinical trial with control group with parallel groups, triple-blind, randomized, phase 2 on 60 patients. Randomization.com was used for randomization.
Settings and conduct
Patients referred to the hematology oncology and radiotherapy oncology department of Imam Reza Hospital, Ghaem or Omid, with obtaining informed consent, they will enter the study. The capsules will be packaged in the factory and identified. Finally, they will be decrypted after completing the data collection.
Participants/Inclusion and exclusion criteria
Metastatic colorectal cancer without NRAS and KRAS mutation or no candidate for target therapy; Under XELOX or FOLFOX regime treatment; Patient consent to enter the study; Eastern cooperative oncology group (ECOG) 0/1; Neutrophil count≥1.5×103/µL; Platelet count≥10×104/µL,hemoglobin≥9g/dL; Creatinine≤1.5 mg/dl; ALT,AST ≤5 ×ULN; total bilirubin≤2×ULN
Intervention groups
Intervention group: capsule nanosilymarin 70 mg prepared by Exiranano Sina company twice a day after meal during 6 21-day courses (XELOX or FOLFOX). Control group: placebo.
Main outcome variables
Periodic radiographic checks for metastatic extent
CRP- CEA- CA19-9
RECIST1.1(Radiographic response of the tumor)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046990N5
Registration date:2020-12-17, 1399/09/27
Registration timing:prospective
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Sepideh Elyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1588
Email address
elyasis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer: A triple blinded, randomized clinical trial
Public title
Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed histological or cytological diagnosis of metastatic colorectal cancer (stage 4) Based on ultrasound results without NRAS and KRAS mutation or no candidate for target therapy(Contraindications or financial incapacity)
Under XELOX or FOLFOX regime treatment
Patient consent to study
Eastern cooperative oncology group (ECOG) 0/ 1
Hemoglobin≥9g/dL، Neutrophil count≥1.5×103/µL, Platelet count≥10×104/µL
Creatinine≤1.5 mg/dl, ALT,AST ≤5 ×ULN، total bilirubin≤2×ULN
Exclusion criteria:
use of other antioxidant
pregnancy or lactation
history of allergy to formulation components
diagnosed with more than one cancer
history of HF
history of autoimmune or immunodeficiency (medical or drug induced) other than chemotherapy
history of HBV or HCV
candidate of curative surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
With the help of a randomization list provided by randomization.com site, patients in the order of inclusion in the study will receive code 1 or 2 and will be included in placebo or medication group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Nano-silymarin and placebo soft gels packages in identical-looking bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Data collection and analysis will be performed by the clinical pharmacy resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences,
Street address
Mashhad University of Medical Sciences,Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9415945344
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.MUMS.REC.1399.503
Health conditions studied
1
Description of health condition studied
Metastatic colorectal cancer
ICD-10 code
C78.5
ICD-10 code description
Secondary malignant neoplasm of large intestine and rectum
Primary outcomes
1
Description
Metastatic extent
Timepoint
Then three courses of chemotherapy and the end of six courses
Method of measurement
Periodic Radiography
2
Description
Assess CRP levels
Timepoint
At the beginning and after the end of three and six chemotherapy courses
Method of measurement
Blood test
3
Description
Assess CEA and CA19-9 levels
Timepoint
At the end of three courses and six courses of chemotherapy
Method of measurement
Blood test
4
Description
Radiographic response of the tumor
Timepoint
Then three courses of chemotherapy and the end of six courses
Method of measurement
(RECIST1.1), based on the doctor's clinical examination
Secondary outcomes
1
Description
Evaluate patient performance
Timepoint
At the end of three and six chemotherapy courses
Method of measurement
EORTC QLQ-C30, based on the doctor's clinical examination
2
Description
Incidence of chemotherapy side effects including neuropathy, HFS; based on the doctor's clinical examination.
Timepoint
At the beginning and end of six courses
Method of measurement
CTCAE v5, based on the doctor's clinical examination.
3
Description
Evaluation of the patient's liver status
Timepoint
At the beginning and end of six courses
Method of measurement
CTCAE v5, based on the doctor's clinical examination and sonography
Intervention groups
1
Description
Intervention group: Nanosiline Marine 70 mg capsule (softgel sinalive 70mg) prepared by Elixir Nanosina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet
Category
Treatment - Drugs
2
Description
Control group: Placebo with the same appearance prepared by Exiranano Sina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Abolghasem Allahyari
Street address
Shariati square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 1588
Fax
Email
allahyaria@mums.ac.ir
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Sare Hosseini
Street address
Koohsangi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3180 1588
Email
hosseinis@mums.ac.ir
3
Recruitment center
Name of recruitment center
Gaem Hospital
Full name of responsible person
Hossein Rahimi
Street address
Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 1588
Email
rahimih@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Pharmacy, Ferdowsi University, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Hedyieh Karbasforooshan
Position
PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdowsi University Campus, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
karbasfh971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hedyieh Karbasforooshan
Position
PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Ferdowsi University Campus, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
karbasfh971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The findings will be published in an article. Study protocol and statistical analysis will be used for article publication.
When the data will become available and for how long
One year after the end of the study it will be published and available in databases.
To whom data/document is available
If the funding sponsor allowed, the findings will be available for researchers, clinicians and scientific centers.
Under which criteria data/document could be used
The other researchers can use our findings in their review articles and meta analysis.
From where data/document is obtainable
For this purpose, you can contact with Sepideh Elyasi at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven, Mashhad, Iran. Email elyasis@mums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will responsible to the query in coordinate with the sponsor within 2 weeks.