Evaluation of prophylactic effect of nano-silymarin in prevention of anthracycline induced cardiotoxicity in breast cancer chemotherapy
Design
This study is a randomized, double-blind, placebo-controlled study. A total of 104 patients will be randomly allocated in two groups of intervention and placebo (each group 52 patients).
Settings and conduct
One-hundred four consecutive breast cancer patients admitted to the oncologist office and planned antracycline-based chemotheraphy, if provide written informed consent will be enrolled in the study. Patients meeting inclusion/exclusion criteria will be randomized in 1:1 ratio to receive silymarin or placebo, two times daily. Trial will be commenced 7 days before starting chemotherapy and continued for 4 courses and at the end, the incidence of cardiotoxicity is evaluated and compared in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who affected with breast cancer
Non-including criteria: the presence of cardiomyopathy; coronary heart disease; mitral valve disease; prior chemotherapy or radiotherapy; alcohol abuse; any contraindications to silymarin; Patients who take other cardiac medications such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, non-dihydropyridine calcium channel blockers, diuretics, statins or beta-blockers.
Intervention groups
Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 4 courses of chemotherapy
Main outcome variables
Echocardiographic evaluation includes measuring the LV end-diastolic (LVEDD) and end-systolic dimensions (LVESD), systolic and diastolic function, discharge fraction and longitudinal global strain for all patients at baseline, and endpoint of chemotherapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046990N17
Registration date:2024-12-22, 1403/10/02
Registration timing:registered_while_recruiting
Last update:2024-12-22, 1403/10/02
Update count:0
Registration date
2024-12-22, 1403/10/02
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
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of nano-silymarin on preventing Anthracycline-Induced cardiotoxicity in patients with breast cancer
Public title
Investigation of the Effect of milk thistle in preventing cardiac complications of chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 y
Patients with breast cancer who planned for antracycline-based chemotherapy
Signing of informed consent by the patient
Exclusion criteria:
Presence of cardiomyopathy (dilated, restrictive or hypertro-phic) detected by baseline echocardiography
History of hypersensitivity to silymarin or similar compounds
Pregnancy and lactation
Past medical history of coronary heart disease Moderate or severe aortic and/or mitral valve disease
Prior chemotherapy or radiotherapy
Alcohol abuse
Patients on other cardiac medications such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, non-dihydropyridine calcium channel blockers, diuretics, statins or beta-blockers
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
104
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 26 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 104 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
2024-08-04, 1403/05/14
Ethics committee reference number
IR.MUMS.REC.1403.219
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Left ventricular (LV) end-systolic and end-diastolic diameters (LVESD, LVEDD), systolic and diastolic function
Timepoint
Echocardiographic measurements including LVESD, LVEDD at baseline. and at 6-month after the start of chemoterapy
Method of measurement
Echocardiography measurements by a specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 4 courses of chemotherapy
Category
Prevention
2
Description
Control group: Placebo capsule for Sinaliv, produced by Exir Nano Sina Company that produced Sinaliv capsules, two tablet daily after breakfast and dinner, for 4 courses of chemotherapy, oral