Evaluation of the relationship between mean heart dose in left breast cancer radiation therapy with Pro-BNP and Troponin values and left ventricular systolic function based on LVEF and GLS values in echocardiography.
Determining the relationship between mean heart dose in left breast cancer radiation therapy with Pro-BNP and Troponin values and left ventricular systolic function based on LVEF and GLS values in echocardiography
Design
Single-arm clinical trial without control group, phase 2 on 37 patients
Settings and conduct
Eligible patients are first examined in Omid Hospital and obtained informed consent and completing the disease questionnaire form, then are referred to Chamran Hospital for echocardiography. Patients will be referred to Chamran Hospital the day before starting and the last day of radiotherapy at Omid Hospital for Troponin and Pro-BNP blood tests, and 6 months later, re-echocardiography will be performed at Chamran Hospital. Finally, the results of the data regarding heart dose delivered in radiotherapy are compared with laboratory and echocardiography values to evaluate the systolic activity of the heart.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients suffering cancer in left breast.
Exclusion criteria: patients under 18 years old; pregnancy; with synchronous cancer or metastasis; history of advanced heart disease or chest radiotherapy; receiving or have received trastuzumab or anthracyclines.
Intervention groups
Patients with left breast cancer undergoing radiotherapy are evaluated for cardiac systolic function before and after radiotherapy with Troponin and Pro-BNP blood tests and echocardiography in terms of heart failure.
Main outcome variables
Mean heart dose; Pro-BNP and Troponin values; Left ventricular systolic function; LVEF and GLS values.
General information
Reason for update
Acronym
Global Longitudinal Strain, Left Ventricle Ejection Fraction
IRCT registration information
IRCT registration number:IRCT20210822052256N2
Registration date:2022-03-17, 1400/12/26
Registration timing:registered_while_recruiting
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Ali Akhavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 0210
Email address
aliakhavan@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-05-15, 1401/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between mean heart dose in left breast cancer radiation therapy with Pro-BNP and Troponin values and left ventricular systolic function based on LVEF and GLS values in echocardiography.
Public title
The effect of left breast radiotherapy on the heart.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with left breast cancer over the age of 18 that have undergone left breast radiation therapy at Omid Hospital
Have not received chemotherapy or just received the TC (taxane-cyclophosphamide) chemotherapy regimen
Exclusion criteria:
Patients under 18 years old
Patients with end stage or metastatic malignancy
Patients with two synchronous cancers
Patients with a history of heart failure with LVEF≤50% or a history of valvular heart disease or advanced congenital heart disease or proven coronary artery disease
Patients with a history of chest radiation therapy
Pregnant patients with breast cancer
Patients receives or have received of anthracyclines and trastuzumab
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine-Isfahan University of Medical Sciences
Street address
Motahari Ave, Omid Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Approval date
2021-08-20, 1400/05/29
Ethics committee reference number
IR.MUI.MED.REC.1400.397
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Heart mean dose in radiation therapy for left breast cancer
Timepoint
Before and 6 months after left breast radiotherapy
Method of measurement
Dose volume histogram
Secondary outcomes
1
Description
Troponin
Timepoint
Before and just after left breast radiotherapy
Method of measurement
Laboratory test
2
Description
Brain natriuretic peptide
Timepoint
Before and just after left breast radiotherapy
Method of measurement
Laboratory test
3
Description
Left ventricle ejection fraction
Timepoint
Before and just after left breast radiotherapy
Method of measurement
Echocardiography
4
Description
Global longitudinal strain
Timepoint
Before and just after left breast radiotherapy
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group: Women with left breast cancer who are treated with conventional 3D or hypofractionated radiation therapy with a dose of 50 Gy in 25 fractions or 42.5 Gy in 16 fractions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Ali Akhavan
Street address
Motahari Ave., Omid Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3235 0214
Email
aliakhavan@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciense
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?