C50.9
Conditions
Interventions
Group 1: Intervention group:
All participants will be recruited from the Sports and Rehabilitation Medicine at the University Hospital of Ulm in Germany. The study aims to randomly assign forty-eight
Sponsors
Sport- und Rehabilitationsmedizin
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Planned cardiotoxic chemotherapy with adjuvant or neoadjuvant intention
Exclusion criteria
Exclusion criteria: Pregnancy, contraindications to MRI examinations (e.g. claustrophobic complaints, ferromagnetic implants), a glomerular filtration rate < 30 ml/min or pre-existing cardiovascular disease (heart failure, a cardiac arrhythmia requiring treatment, coronary heart disease, a past pulmonary artery embolism, previous cardiac surgery or a congenital heart defect). Orthopaedic and functional conditions that do not permit sporting activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of symptomatic or asymptomatic cancer therapy-related cardiac dysfunction (CTRCD): Structured physical exercise, including high intensity interval training (HIIT) and high intensity resistance training (HIRT), may reduce the primary endpoint, which is the occurrence of symptomatic or asymptomatic cancer-therapy related cardiac dysfunction (CTRCD) in breast cancer patients undergoing cardiotoxic cancer therapies. This potential occurrence is assessed at three distinct time points (at the baseline examination, after 6 months, and after 12 months), utilizing transthoracic echocardiography and various cardiac magnetic resonance (CMR) sequences and the measurement of cardiac biomarkers. CTRCD is defined according the current ESC guidelines as a decrease in LVEF by more than 10% to below 50%, or a drop greater than 15% in GLS from baseline, indicating subclinical LV dysfunction. It may also include a new elevation in cardiac biomarkers such as troponin T above the 99th percentile or NT-proBNP = 125 pg/ml. The echocardiographic evaluation includes measurements of cardiac structure and function, as well as markers for subclinical cardiac dysfunction, including longitudinal, radial, and circumferential strain. Additionally, non-invasive-tissue characterization parameters on CMR, such as native T1 time, T2 time, post-contrast T1 time for determining extracellular volume, and late gadolinium enhancement (LGE), are assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Signs of cardiac inflammation: Detecting changes from baseline (t1) to follow-up (t2) and final examination (t3) by CMR imaging Mitochondrial dysfunction: Mitochondrial and molecular markers (galectin-3, klotho, kynurenine, cell-free mtDNA and nDNA, musclin, NRF2, PGC-1a, rhodanase) Health-related quality of life: EQ-5D questionnaire Fatique: EORTC5QLQ-FA12 questionnaire Depression: PHQ-9 questionnaire Anxiety: GAD-7 questionnaire Average heart rate: Tracked by the fitness watch Heart rate variability (HRV): Tracked by the fitness watch Step count and daily physical activity: Tracked by the fitness watch Blood pressure: Assessment at baseline (t1), follow-up (t2) and final examination (t3) Exercise capacity: CPET with assessment of VO2peak, and maximum power Strength capacity: Grip strength Anthropometry: Body weight, Body mass index (BMI), Fettmasse (FM), Freie Fettmasse (FFM), waist-to-height-ratio | — |
Countries
Germany
Contacts
Public ContactJana Schellenberg
Sport-und Rehabilitationsmedizin
Outcome results
None listed