Oxidative stress is known as the most acceptable mechanism of anthracycline-induced cardiotoxicity. Considering the anti-oxidant and anti-inflammatory effects of ginseng supplement, the purpose of this study is to evaluate the effect of ginseng supplement in the prevention of anthracycline-induced cardiotoxicity in non-metastatic breast cancer patients.
Design
This is a randomized, double blind, placebo controlled clinical trial.
Settings and conduct
Participants, care provider, outcome assessors and analysts are blinded in this study.
Participants/Inclusion and exclusion criteria
Sixty two patients aged 18 to 65 years with non-metastatic breast cancer who have received their first course of anthracycline based chemotherapy regimen will be randomly assigned into two groups; the intervention and the control group.
The patients with the following factors will be excluded from the study: history of anthracyclines therapy, history of having solid tumors that received systemic therapy, metastatic or recurrent breast cancer, LVEF below 50%, history of chronic diseases (DM, cardiac disease, renal failure), pregnant and breast-feeding wemon.
Intervention groups
The intervention group will be received 1g ginseng daily (4 capsules containing 250 mg of ginseng rhizome powder, standardized based on 6.3-7.7 mg ginsenoside of Rg1) and the control group will be received 1g placebo daily (4 capsules containing 250 mg starch) beside the standard chemotherapy regimen for 3 months (until the end of the last chemotherapy coarse which has 4 cycles administered each 3 weeks).
Main outcome variables
Cardiotoxicity evaluation with LVEF and Trop I will be assessed baseline and after completion of the 3 months chemotherapy coarse.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141227020441N7
Registration date:2020-01-19, 1398/10/29
Registration timing:registered_while_recruiting
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of ginseng supplement in the prevention of cardiac toxicity induced by anthracyclines in breast cancer patients
Public title
The efficacy of ginseng supplement in the prevention of cardiac toxicity induced by anthracyclines
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The ages of 18 to 65 years
Patients with non-metastatic breast cancer
Receiving the first course of anthracycline based chemotherapy
Exclusion criteria:
History of therapy with anthracyclines
Metastatic or recurrent breast cancer
History of solid tumors and receiving systemic therapy
LVEF below 50%
History of chronic diseases ( DM, cardiac disease. renal failure)
Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is conducted by the table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Paticipants, care provider, outcome assessor and data analyser are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for research, Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz
Street address
Shiraz University of Medical Sciences, Deputy for research
City
Shiraz
Province
Fars
Postal code
7146864685
Approval date
2019-02-13, 1397/11/24
Ethics committee reference number
IR.SUMS.REC.1398.609
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
I42.7
ICD-10 code description
Cardiomyopathy due to drug and external agent
Primary outcomes
1
Description
Cardiotoxicity will be assessed based on LVEF and Trop I
Timepoint
will be evaluated baseline and after completion of chemotherapy cycles (3 monthes).
Method of measurement
LVEF and Trop I will be assessed with echocardiography and blood samples respectively.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The standard chemotherapy regimen beside 1g ginseng daily for 3 monthes
Category
Prevention
2
Description
Control group: The standard chemotherapy regimen beside 1g capsules containing starch daily for 3 monthes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir hospital
Full name of responsible person
Farzaneh Foroughinia
Street address
Amir hospital, in front of Kowsar pool, Rajaei Blvd, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۸۷۹۱۵۹۹۸
Phone
+98 71 3632 3532
Email
foroughinia@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Street address
Karafarin street, School of pharmacy
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 17 3242 6122
Email
foroughinia@sums.ac.ir
Grant name
Shiraz University of Medical Sciences, Vice Chancellor of Research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 7132424128233
Email
foroughinia@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3230 5410
Email
foroughinia@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Profesoor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4128
Email
foroughinia@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available