Investigating the efficacy and safety of Curcumin on the prevention of non-alcoholic fatty liver disease (NAFLD) in patients with non-metastatic breast cancer receiving tamoxifen
General purpose:
Investigating the effectiveness and safety of curcumin on the prevention of fatty liver in patients with non-metastatic breast cancer receiving tamoxifen.
Design
Patients are checked wit ultrasound for the accumulation of fat in the liver, and blood tests of the patients are measured and recorded. Then the patients are randomly assigned to the curcumin group or the placebo group so that the patient, the researcher and the statistician analyzing the results do not know the treatment group of the patients.
Settings and conduct
Patients in the curcumin group receive 500 mg of curcumin daily for 6 months. Patients in the placebo group also use placebo for 6 months. After the end of the 6-month period, liver ultrasound and liver enzyme tests are repeated for all patients. During this period, the patients are requested to inform the research team in case of any complications. Also, to follow up the correct use of the medicine by the patients, the patients are contacted by phone once a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Women with non-metastatic breast cancer whose pathology is positive in terms of hormone receptors and are treated with tamoxifen.
2. Normal liver enzymes
3. No history of chemotherapy
Exit criteria:
1. The patient's unwillingness to continue the study
2. Having liver diseases during the study
3. The use of alcohol or drugs with hepatotoxicity such as methotrexate, amiodarone, valproic acid, and anabolic steroids, as well as the use of anticoagulant and antiplatelet drugs after the start of the study.
4. Suffering from any related disease and distorting the results during the study
5. Having or developing an allergy to curcumin medicine
6. Creating metastasis during the study
Intervention groups
500 mg curcumin drug daily for 6 months
Main outcome variables
Fatty liver grade
Liver enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240501061618N1
Registration date:2024-05-07, 1403/02/18
Registration timing:prospective
Last update:2024-05-07, 1403/02/18
Update count:0
Registration date
2024-05-07, 1403/02/18
Registrant information
Name
Fateme Mehrabi nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3438 1902
Email address
f.mehrabinejad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy and safety of Curcumin on the prevention of non-alcoholic fatty liver disease (NAFLD) in patients with non-metastatic breast cancer receiving tamoxifen
Public title
The effect of Curcumin on the prevention of fatty liver caused by tamoxifen
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with non-metastatic breast cancer whose pathology is positive in terms of hormone receptors and are treated with tamoxifen.
Normal liver enzymes
Not having viral hepatitis
Not having a history of alcohol consumption
Not using drugs with hepatotoxicity such as methotrexate, amiodarone, valproic acid, anabolic steroids, as well as the use of anticoagulant and antiplatelet drugs.
Insensitivity to curcumin drug
No history of chemotherapy
Exclusion criteria:
The patient's unwillingness to continue the study
Having liver diseases during the study
The use of drugs with hepatotoxicity such as methotrexate, amiodarone, valproic acid, anabolic steroids, as well as the use of anticoagulant and antiplatelet drugs after the start of the study.
Suffering from any related disease and distorting the results during the study
Allergic to curcumin drug
Development of Metastasis during the study
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple individual randomization method is used. Patients are divided into two equal groups (odd numbers: intervention group, even numbers: control group) using non-repeating random numbers between 1 and 44 by the software. Then the envelope with the same number is given to the patient, in which full explanations about the research items and how to follow up the treatment are explained. Also, the researcher gives complete explanations to the doctors during the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient and the patient's treatment team, as well as the radiologist who reports the result of fatty liver, do not know about the patient's treatment group. The treatment team treats the patient's breast cancer based on current standards without any changes and they do not need to know the patient's research group.
Only the researcher knows about the research group of patients so that there is no mistake in receiving medicine and follow-ups.
The results are recorded in a data file without the name of the patient and treatment groups with numbers 1 and 2. Also, the statistician analyzing the results will not know the type of groups.
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
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.MUI.MED.REC.1403.041
Health conditions studied
1
Description of health condition studied
Fatty liver caused by tamoxifen in patients with non-metastatic breast cancer
ICD-10 code
C50.91
ICD-10 code description
Malignant neoplasm of breast of unspecified site, female
Primary outcomes
1
Description
Fatty liver grade
Timepoint
6 months
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Liver enzyme level
Timepoint
6 months
Method of measurement
Lab blood test
Intervention groups
1
Description
Intervention group: The patient takes one capsule containing 500 mg of curcumin (produced by Karen Pharma) daily for 6 months. Before the patients enter the study, complete explanations about the randomization method and the intervention and control groups are given orally for 1 hour for each patient, as well as a complete brochure including the necessary explanations and contact information when necessary.
Category
Prevention
2
Description
Control group: The patient consumes a placebo capsule daily, similar to 500 mg curcumin capsule of Karen Pharma company, which is prepared by the Faculty of Pharmacy. Before the patients enter the study, complete explanations about the randomization method and the intervention and control groups are given orally for 1 hour for each patient, as well as a complete brochure including the necessary explanations and contact information when necessary.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-Shohada Hospital
Full name of responsible person
Fatemeh Mehrabi Nejad
Street address
Isfahan, Khayyam Street, Nehar Farshadi Street, Seyed Al Shahada Hospital
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 293 5891
Email
f.mehrabinejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Simin Hemmati
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@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
Fatemeh Mehrabi Nejad
Position
Radio Oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Hematology
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 293 5891
Email
f.mehrabinejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi Nejad
Position
Radio Oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Hematology
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 293 5891
Email
f.mehrabinejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi Nejad
Position
Radio Oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Hematology
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 293 5891
Email
f.mehrabinejad@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions and individuals in the pharmaceutical industry
Under which criteria data/document could be used
not applicable
From where data/document is obtainable
via email
What processes are involved for a request to access data/document
The requester's profile, the reason for the request, and the type of analysis to be performed