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Studies

Observational Recruiting

NCT06334445 on ClinicalTrials.gov

CARDIOCARE Prospective Clinical Study

Official title: CARDIOCARE Prospective Clinical Study An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient With Breast Cancer Therapy Induced Cardiac Toxicity

  • Sponsor: European Institute of Oncology
  • Enrollment: 736 (Estimated)
  • Study start: 2023-09-14 (Actual)
  • Primary completion: 2024-12-31 (Estimated)
  • Study completion: 2024-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy.

Conditions

  • Breast Cancer

Intervention / Treatment

  • Behavioral: Control group
  • Behavioral: Intervention group

Primary Outcome Measures

  • Evaluation of the onset of cardiotoxicity (12 months)
    Subclinical cardiotoxicity is defined as preserved Left Ventricular Ejection Fraction (LVEF) with \>15% reduction in Global Longitudinal Strain (GLS) relative to baseline and/or new rise in cardiac Troponin I or Natriuretic peptides levels in plasma. Clinical cardiotoxicity is defined as the reduction of LVEF by ≥ 10% from baseline to a value below 50%, incurred at any timepoint during study Follow Up (FU)

Countries

Italy

Locations and Investigators

  • European Institute of Oncology, Milan, Italy (Recruiting)
    • Gabriella Pravettoni

Study Officials