CARDIOCARE Prospective Clinical Study

NCT06334445 | Recruiting

• 1 other identifier: IEO 1874
• Study Type: observational
• Target: 736
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the onset of cardiotoxicity

  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)

  12 months

Secondary Outcomes (8)

• Intra-patient assessment of major adverse cardiac events (MACEs)

  12 months

• Intra-patient assessment of plasma Troponin I

  12 months

• Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation

  12 months

• Percentage in the two arm of hospital admission

  12 months

• Number of Cardiovascular death in the two arms

  12 months

Study Arms (2)

Control group

Wearables/sensors and ePsycHeart App

Behavioral: Control group

Intervention group

Wearables/sensors and ePsycHeart App and eHealtHeart

Behavioral: Intervention group

Interventions

Control group BEHAVIORAL

Wearables/sensors and ePsycHeart App

Control group

Intervention group BEHAVIORAL

Wearables/sensors and ePsycHeart App and eHealtHeart

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The prospective clinical study will enroll a total of 750 breast cancer patients over 12 months.

You may qualify if:

• Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant and/or adjuvant treatment with regimens including anthracyclines and/or taxanes.
• Women ≥ 60 years with a diagnosis of HER2-positive locoregional breast cancer who will undergo neoadjuvant and/or adjuvant treatment with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab).
• Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant and/or adjuvant treatment with endocrine therapies +/- CDK 4/6 inhibitors.
• Women ≥ 60 years with HER2-positive metastatic breast cancer who will undergo first-line therapy with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab +/- chemotherapy).
• Women with age ≥ 60 years before starting the aforementioned treatment for breast cancer.
• Women eligible ≥ 60 years who will undergo first-line therapy in the metastatic setting with any type of treatment (chemotherapy, immunotherapy, biological agents).
• Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
• Written informed consent.
• Participant affiliated to a social security system.
• Life expectancy of at least 12 months.

You may not qualify if:

• Age \< 60 years.
• Diagnosed severe psychiatric or neurological disorders that might impair the ability to give informed consent.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

Related Publications (1)

• Sacco GGA, Mazzocco K, Constantinidou A, Papakonstantinou A, Mauri D, Kalliatakis G, Tsiknakis M, Ribnikar D, Tsekoura D, Aidarinis V, Keramida K, Oikonomopoulos P, Antoniades A, Brown C, Rizzi F, Bucur A, Pacella E, Karanasiou G, Cardinale D, Cipolla C, Munzone E, Fotiadis D, Curigliano G, Pravettoni G. An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study. JMIR Res Protoc. 2025 Aug 14;14:e63455. doi: 10.2196/63455.

  PMID: 40810441 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma, stool

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

+39 02 57489.731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: September 14, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IT (1)