Evaluation of prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy: a randomized controlled clinical trial
Evaluation of the prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy
Design
Clinical trials with control group with randomized, multifaceted, randomized,randomized groups
Settings and conduct
Evaluation of the effect of pharmacological intervention on the prevention of liver damage caused by chemotherapy in cancer patients referred to outpatient clinics affiliated to Isfahan University of Medical Sciences that have chemotherapy indications. Blinding of groups for clinicians, researchers and data analysts.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients aged 30 to 60 years with the ability to take the drug orally with no pregnancy and lactation and a definite diagnosis of breast cancer who have chemotherapy indications and have not yet received their chemotherapy drug and liver tests are normal before intervention and without liver metastasis and disease.
Intervention groups
Daily administration of two 140 mg silymarin tablets one week before the start of the chemotherapy course in the intervention group 1 and two daily silymarin 140 mg tablets simultaneously with the start of the chemotherapy course in the intervention group 2 and placebo tablets in the control group
Main outcome variables
The main consequences are liver function variables including ALT, AST, BILIRUBIN, ALP tests.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201123049474N2
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Mohammad Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 2884
Email address
dr.mohamad.amin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy: a randomized controlled clinical trial
Public title
Evaluation of prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 30 to 60 years
Ability to take the drug orally
Definitive diagnosis of breast cancer that has chemotherapy indications and has not yet received its chemotherapy drug
Liver tests are normal before the intervention
Indication of treatment with chemotherapy regimen
Exclusion criteria:
pregnant and breastfeeding
liver metastasis and liver disease
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of six balanced block randomization in such a way that in each block with different possibilities, there are two cases A, two cases B and two cases C. Each letter represents the study groups. Creating random values to be assigned to blocks is done in spss software. Then, an independent person from the research team encodes 105 envelopes (based on the codes obtained in the above randomization method) and determines the list of codes. The inside of the envelope will be written according to the above new treatment method or standard (conventional) treatment and in the order of eligible patients entering the clinic, patients will be given to give to the oncologist. The treating physician will prescribe and make the necessary recommendations for each patient based on the grouping performed. The researcher is also unaware of which group each patient is in.
Blinding (investigator's opinion)
Double blinded
Blinding description
The secretary introduced the patients to the oncologist using a randomized grouping and the oncologist provided treatments for all groups according to the grouping done.The investigator,in collaboration with the oncologist,supervised the patient's use of the drug. After collecting the laboratory data, the results was analyzed by a statistician specialist with respect to the confidentiality of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Ethics committee of Isfahan medical university, Building No. 4, Isfahan medical university, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.MUI.MED.REC.1399.763
Health conditions studied
1
Description of health condition studied
Chemotherapy induced liver injury
ICD-10 code
S36.11
ICD-10 code description
Injury of liver
Primary outcomes
1
Description
liver function test
Timepoint
Measurement of liver enzymes at the beginning of the study (before the intervention) and 3 and 6 weeks after the start of silymarin
Method of measurement
Lab data
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first treatment group receives two 140 mg silymarin tablets one week before the start of the chemotherapy course and is taken daily for two months after the chemotherapy treatment.
Category
Prevention
2
Description
Intervention group: The second treatment group receives two 140 mg silymarin tablets from the start of the chemotherapy course and is taken daily for two months after chemotherapy.
Category
Prevention
3
Description
Control group: They receive two placebo tablets daily for two months from the time of chemotherapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra clinics
Full name of responsible person
Ali Hajigholami
Street address
Sheikh Mofid Street
City
Isfahan
Province
Isfehan
Postal code
8163743787
Phone
+98 31 3663 1677
Email
Ali_hajigholami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooye Javaanmard
Street address
Hezar Jarib Street-Vice Chancellery of Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Safoora Sadat Erfanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1991
Email
S.erfanian72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Houriye Ansari
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Department of Social and Family Medicine
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8123
Email
houri_|ansari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safoora Sadat Erfanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1991
Email
S.erfanian72@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data in the study except for personal data can be shared.
When the data will become available and for how long
The start of the access period is 6 months after the results are printed.
To whom data/document is available
At the current stage,the results will be available to researchers at university institutes.
Under which criteria data/document could be used
In terms of data analysis and analysis for academic researchers and use in later studies.
From where data/document is obtainable
School of social medicine,Isfahan Ali_hajigholami@yahoo.com
What processes are involved for a request to access data/document
By submitting a written request to the director of the Social Medicine School, Isfahan