Evaluation and comparison of fatty liver with Tamoxifen and Letrozole in premenopausal breast cancer patients
Design
Progesterone receptor or Estrogen receptor positive patients who meet the conditions to enter the study are included in the study by continuous sampling method. They are treated with chemotherapy. They are divided into two groups by random allocation method. The first group of breast cancer patients are treated with tamoxifen and the second group with Letrozole. In both groups, in two stages, once after the completion of chemotherapy and the second time at least 6 months after taking tamoxifen and Letrozole drugs, abdominal ultrasound is performed to evaluate fatty liver.
Settings and conduct
In both groups of menopausal patients with Brest cancer referred to Qazvin Velayat Hospital and private practice (under treatment with tamoxifen and letrozole) in two stages, once after completion of chemotherapy and the second time at least 6 months after taking tamoxifen and letrozole drugs. Abdominal examination is done to evaluate fatty liver.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include premenopausal breast cancer patients (PR or ER positive) and the exclusion criteria include having any risk factor for fatty liver or underlying liver problems (abdominal ultrasound is used to check for fatty liver) If there is evidence in favor of fatty liver, they are excluded from the study.)
Intervention groups
The first group of Brest cancer patients are treated with tamoxifen and the second group with letrozole
Main outcome variables
Alanine transaminase
Aspartate Transaminase
Severity of fatty liver
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056616N1
Registration date:2022-12-08, 1401/09/17
Registration timing:prospective
Last update:2022-12-08, 1401/09/17
Update count:0
Registration date
2022-12-08, 1401/09/17
Registrant information
Name
Mohammad Nazarinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 3721
Email address
m.nazarinia99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and Comparing the Association of Fatty Liver with Tamoxifen and Letrozole in Premenopausal Patients with Breast Cancer
Public title
Investigating and Comparing the Association of Fatty Liver with Tamoxifen and Letrozole in Premenopausal Patients with Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premenopausal breast cancer patients (Progesterone receptor or Estrogen receptor positive).
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Progesterone receptor or Estrogen receptor positive patients who meet the conditions to enter the study are included in the study by continuous sampling method. They are treated with chemotherapy. They are divided into two groups by random allocation method. The first group of breast cancer patients are treated with Tamoxifen and the second group with Letrozole.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2022-11-23, 1401/09/02
Ethics committee reference number
IR.QUMS.REC.1401.246
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Severity of fatty liver
Timepoint
6 months after taking tamoxifen and letrozole drugs
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Brest cancer treated with Letrozole
Category
Treatment - Drugs
2
Description
Control group: Patients with Brest cancer treated with Tamoxifen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Mohammad Nazarinia
Street address
22 Bahman Blvd., Minoodar region
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
m.nazarinia99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Nazarinia
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
medicine@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Nazarinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.nazarinia99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Nazarinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.nazarinia99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Nazarinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.nazarinia99@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
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