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Breast CancerCARDIOCARENCT06334445

CARDIOCARE Prospective Clinical Study

An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Intervention group
How many people
736 participants
Where
1 siteItaly
Study dates
14 Sep 2023to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).
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  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Gabriella Pravettoni contact

+39 02 57489.731

gabriella.pravettoni@ieo.it

Italy1 site, 1 recruiting

  • European Institute of Oncology

    Milan

    Gabriella Pravettoni

    Recruiting

Other trials in Italy

About this 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

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.

Read the detailed description

This is a prospective observational study for women with diagnosis of Breast Cancer (BC) who will undergo neoadjuvant and/or adjuvant treatment:

  1. Women ≥ 60 years with a diagnosis of HER2-positive early/locoregional breast cancer with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab)
  2. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will un-dergo neoadjuvant and/or adjuvant treatment with regimens including anthracy-clines and/or taxanes
  3. Women ≥60 years with a diagnosis of early/locoregional breast cancer who will un-dergo neoadjuvant and/or adjuvant treatment with endocrine therapies +/- CDK 4/6 inhibitors
  4. Women ≥ 60 years with HER2-positive metastatic breast cancer who will undergo first-line therapy with anti-HER2 therapy (trastuzumab or trastuzumab and per-tuzumab +/- chemotherapy).

The study primary objective is to evaluate the onset of cardiotoxicity, where: subclinical car-diotoxicity is defined as preserved Left Ventricular Ejection Fraction (LVEF).

All patients will receive, in addition to standard of care, supportive care. Patients in the control and in the intervention group will receive wearable and will be invited to complete the mobile ePsycHeart evaluation. ePsycHeart will assess patients' intrinsic capacity indicators that may be associated with including

  1. psycho cognitive states (psychological and emotional states, QoL, cognitive function and memory, perceptions of aging, environmental and social factors),
  2. mobility and locomotion (distance, balance, gait speed), and
  3. vitality (exercise, electrocardiogram (ECG), Heart Rate Variability (HRV), grip strength, nutritional/energy state, sleep, fatigue), will be performed by means of sensors, wearables, electronic devices and validated patient reported outcome- and experience measures.

In addition, patients in the intervention group will receive the eHealtHeart: Behavioral and psychological interventions will be delivered to the intervention arm via the eHealtHeart mobile application to mitigate potential risk factors associated with cardiotoxicity and deterioration of QoL. eHealtHeart interventions will target patients and care givers aiming at improving patients' intrinsic capacity including psychological inter-ventions (e.g. emotional, dispositional states, biofeedback self-regulation, best possible self), cognitive stim-ulation (e.g. cognitive restructuring plus card games to improve memory and executive functions), sensory screening, physical activity and performance exercises, vision and hearing suggestions, dietary guidance on nutrition, guidance to improve management of urinary inconti-nence (e.g. alerts, self-monitoring) and falls together with providing education and support to caregivers. At month 6 the patient will have to return the wearables used for the study.

Conditions
Breast Cancer
Being tested
Control group, Intervention group
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupBehavioural

    Wearables/sensors and ePsycHeart App

  • Intervention groupBehavioural

    Wearables/sensors and ePsycHeart App and eHealtHeart

Study groups in NCT06334445
Study groupRoleWhat they receive
Control groupWearables/sensors and ePsycHeart App
Receives: Behavioral: Control group
Intervention groupWearables/sensors and ePsycHeart App and eHealtHeart
Receives: Behavioral: Intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (8)

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

    1. Angina pectoris;
    2. Acute myocardial infarction;
    3. Major ventricular arrhythmias;
    4. Pacemaker implantation;
    5. Acute heart failure (New York Heart Association (NYHA) class 4);
    6. Acute ischemic brain disease with neurological persistence evidence;
    7. Severe hypertension requiring treatment with Angiotensin-converting enzyme (ACE) and or beta blockers.

    Measured: 12 months

  2. Intra-patient assessment of plasma Troponin I

    Intra-patient assessment of plasma Troponin I during follow up and association/agreement with LVEF

    Measured: 12 months

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

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

    Measured: 12 months

  4. Percentage in the two arm of hospital admission

    Hospital admissions from cardiovascular causes or falls in order to evaluate the percentage in the two arms

    Measured: 12 months

  5. Number of Cardiovascular death in the two arms

    Number of Cardiovascular death in the two arms

    Measured: 12 months

  6. Number of Non-cardiovascular death in the two arms

    Number of Non-cardiovascular death in the two arms

    Measured: 12 months

  7. Evaluation of Health Related Quality of Life in the two arms

    Evaluation of Health Related Quality of Life in the two arms assessed by EORTC QLQ-BR23, validated breast cancer Patient Re-ported Outcome Measure (PROM)

    Measured: 12 months

  8. Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms

    Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-ad-justed life-years (QALYs). Costs will consider healthcare provided, numbers of admission and days spent in hospital and patient costs for out-of-pocket expenses associated with their condition (i.e., travel expenses (of both patient and caregiver), over-the-counter medicines and supplements, com-plementary therapies not supported by Healthcare system, home help, and time away from work).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start14 Sep 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
736 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334445
Sponsor's protocol ID
IEO 1874
Acronym
CARDIOCARE
Status last verified
Mar 2024
First submitted
21 Mar 2024
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40810441

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gabriella Pravettoni (+39 02 57489.731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the onset of cardiotoxicity (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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CARDIOCARE Prospective Clinical Study (NCT06334445) | AzTrials