Evaluation of oral nano-silymarin formulation efficacy in prevention of hepatotoxicity induced by doxorubicin-cyclophosphamide chemotherapy regimen in patients with non-metastatic breast cancer
Evaluation of oral nano Silymarin formulation efficacy in prevention of hepatotoxicity induced by Doxorubicin containing chemotherapy regimen in patients with non-metastatic breast cancer
Design
This is a randomized triple-blind, parallel group clinical trial on 70 patients with non-metastatic breast cancer (35 patients in treatment group and 35 patients in placebo group).
Settings and conduct
This study will be performed on 70 non-metastatic breast cancer patients referring to Imam Reza Hospital, Mashhad, Iran. They whether will receive 2 nano silymarin 70 mg capsules for 4 courses in treatment group or 2 placebo capsules in placebo group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Non-metastatic breast cancer undergoes chemotherapy with a regimen containing doxorubicin after a mastectomy. 2. Age between 18 to 65 years 3. Signing the informed consent by the patient. Non-Inclusion criteria: 1. Viral hepatitis 2. History of allergy to Silymarin or other similar compounds 3. Pregnancy or lactation 4. Liver involvement grade 2 or higher based on liver ultrasound. Exclusion criteria: 1. Changing the chemotherapy regimen 2. The patient unwillingness for medication use.
Intervention groups
Intervention group: two of 70 mg nano Silymarin capsules daily (one capsule after breakfast and one capsule after dinner) during 4 courses of chemotherapy. Placebo group: two placebo capsules/day for 4 courses of chemotherapy (with same appearance of nano Silymarin capsule containing all nano Silymarin capsule ingredients except nano Silymarin)
Main outcome variables
liver enzymes serum level & ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046990N13
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
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
2023-09-23, 1402/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral nano-silymarin formulation efficacy in prevention of hepatotoxicity induced by doxorubicin-cyclophosphamide chemotherapy regimen in patients with non-metastatic breast cancer
Public title
Evaluation of oral nano-silymarin formulation effect in prevention of liver damage induced by doxorubicin-cyclophosphamide chemotherapy regimen in patients with non-metastatic breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 y
Patients with diagnosis of non-metastatic breast cancer who will be treated by doxurobicin after mastectomy
Signing the written consent
Exclusion criteria:
Viral hepatitis
History of hypersensitivity to silymarin or similar compounds
Pregnancy and lactation
Any kind of liver injury resulting in rise of liver enzymes or bilirubin to higher than upper limit normal
Renal failure
Concomitant use of heptotoxic agents or antioxidants
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 18 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 70 patients will enter the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The nano Silymarin and placebo capsule (prepared by Mashhad Pharmacy School) will be packaged in boxes with same appearance and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study and will receive a box filled with medication or placebo respectively. Patients will be evaluated during the treatment course by the physician. Data collection and analysis will be performed by the pharmacy student and the clinical pharmacist. All of them will be unaware patients' grouping 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
Ethics committee of Mashhad University of Medical Sciences
Street address
Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.MUMS.REC.1402.075
Health conditions studied
1
Description of health condition studied
Non-metastatic breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Serum level of hepatic transaminases
Timepoint
At the beginning of the study, 4 weeks after the beginning of study, at the end of study
Method of measurement
Serum level measurement by the laboratory
2
Description
Liver ultrasound to determine the stage of the fatty liver
Timepoint
At the beginning of the study and at the end of study
Method of measurement
Ultrasound evaluation
3
Description
Serum level of total and direct billirubin
Timepoint
At the beginning of the study, 4 weeks after the beginning of study, at the end of study
Method of measurement
Serum level measurement by the laboratory
4
Description
prothrombin time
Timepoint
At the beginning of the study, 4 weeks after the beginning of study, at the end of study
Method of measurement
Serum level measurement by the laboratory
5
Description
serum albumin level
Timepoint
At the beginning of the study, 4 weeks after the beginning of study, at the end of study
Method of measurement
Serum level measurement by the laboratory
6
Description
Serum level of alkalin phosphatase
Timepoint
At the beginning of the study, 4 weeks after the beginning of study, at the end of study
Method of measurement
Serum level measurement by the laboratory
Secondary outcomes
1
Description
Serum level of creatinine and urea
Timepoint
At the beginning of the study, 2 weeks after the beginning of study and at the end of study
Method of measurement
Serum level measurement by the laboratory
Intervention groups
1
Description
Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule for sinalive, two tablet daily after breakfast and dinner, for 8 week, oral
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital, affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Street address
Imam Reza Sq.
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
Email
elyasis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mouhebati
Street address
Faculty of Medicine, Ferdowsi University, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
mouhebatim@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
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
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
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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 response to the query in coordinate with the sponsor within 2 weeks