An interventional study of Helical tomotherapy for breast cancer in Toxicity Due to Radiotherapy, Breast Cancer and Lesion; Cardiac, sponsored by Sophie JACOB. Withdrawn at 1 site in France. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by Sophie JACOB · Not applicable, Interventional, and Diagnostic
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.
In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples
Other: Helical tomotherapy for breast cancer
1. At baseline, before helical tomotherapy is performed, for each included woman will have: * measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, ..., microparticles and miRNA) * cardiologic examination including echocardiography for measurement of strain and strain rate * a CT coronary angiogram for measurement of coronary plaque indexes 2. Helical tomotherapy will be performed for all women included in the cohort. 3. At the end of tomotherapy, follow-up will include: * measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy * cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy * A CT coronary angiogram 24 months after radiotherapy
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .
Time frame: within the first 2 years after tomotherapy
Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
Time frame: within the first 6 months after tomotherapy
Number of participants with modified measures of circulating biomarkers
Time frame: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)
This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Sophie JACOB