A Study of Radiation Therapy-Induced Heart Damage in Patients with Breast Cancer
- Gender
- Women and men
- Age
- 18 years and older
- Trial type
- Interventional
- Line of therapy
- all
- Phase
- —
What is this trial about?
Radiation therapy is an important part of treating breast cancer. However, it can also damage the heart, since it is located near the area being treated. The goal of the CorTox study is to investigate which diagnostic methods are suitable for predicting radiation therapy-induced heart damage at an early stage. Women and men aged 18 and older with non-small-cell lung cancer or esophageal cancer, and women aged 18 and older with breast cancer who are scheduled to receive curative radiation therapy or chemoradiation therapy, are eligible to participate in this study.
Trial flow
Requirements
Diagnosis: non-small cell lung cancer, oesophageal cancer, breast cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: curative treatable; radiotherapy to the chest area is planned; for breast cancer: women only
Allocation
Einarmige Studie
Treatment
Follow-up
Diagnosis: non-small cell lung cancer, oesophageal cancer, breast cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: curative treatable; radiotherapy to the chest area is planned; for breast cancer: women only
Einarmige Studie
Detailed description
Cancers in the chest area, such as non-small cell lung cancer (NSCLC), esophageal cancer, or breast cancer, are often treated with radiation therapy. This is used either on its own or in combination with chemotherapy, in what is known as chemoradiation therapy. An unavoidable side effect of radiation therapy is that surrounding healthy tissue—particularly the heart—can also be affected by the radiation. Radiation therapy-induced heart damage (cardiotoxicity) can lead to serious cardiovascular diseases, which often do not manifest until years after treatment. However, there are currently no reliable methods for assessing an individual’s risk of such heart damage at an early stage.
The aim of this study is to investigate various methods for predicting radiation therapy-induced heart damage. To this end, several tests will be performed on the patients before, during, and after radiation therapy: a magnetic resonance imaging (MRI) scan of the heart, an electrocardiogram (ECG), an ultrasound examination of the heart (echocardiography), and blood tests to determine specific blood values (biomarkers). These results are compared with radiation treatment data to determine which factors can predict heart damage. The study includes two cohorts: Cohort 1 consists of patients with non-small-cell lung cancer or esophageal cancer, while Cohort 2 consists exclusively of women with breast cancer. All patients undergo the same diagnostic tests. The study is not testing a new drug but is investigating whether the aforementioned diagnostic methods are suitable for predicting heart damage. The primary objective is to identify heart damage of Grade 2 or higher one or five years after the end of radiation therapy.
Women and men aged 18 and older with non-small cell lung cancer or esophageal cancer, and women aged 18 and older with breast cancer who are scheduled to receive curative radiation therapy or chemoradiation therapy, are eligible to participate in this study.
Facts
- Which disease: non-small-cell lung cancer, esophageal cancer, breast cancer
- Cancer characteristics: curable, radiation therapy planned for the chest area
- What the study investigates: diagnostic methods (MRI, ECG, echocardiography, blood biomarkers) for detecting radiation therapy-induced heart damage
- Study objective: To evaluate various methods for predicting radiation therapy-induced heart damage
- Study duration: Up to approximately 5 years after completion of treatment (lung and esophageal cancer) or up to approximately 10 years (breast cancer)
- Study characteristics: open-label (unblinded), two cohorts, all patients undergo the same examinations
Trial sites
1 trial site in Germany is listed.
Universitätsklinikum Carl Gustav Carus Dresden
01304 Dresden
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT06986291) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.