CARDIOCARE Prospective Clinical Study

Breast Cancer Clinical Trial

— CARDIOCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334445
• Other study ID #: IEO 1874
• Status: Recruiting
• Start date: September 14, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +39 02 57489.731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 736
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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).

3. 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.

4. 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).

5. Women with age = 60 years before starting the aforementioned treatment for breast cancer.

6. Women eligible = 60 years who will undergo first-line therapy in the metastatic setting with any type of treatment (chemotherapy, immunotherapy, biological agents).

7. Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures

8. Written informed consent.

9. Participant affiliated to a social security system.

10. Life expectancy of at least 12 months.

Exclusion Criteria:

1. Age < 60 years.

2. Diagnosed severe psychiatric or neurological disorders that might impair the ability to give informed consent.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Control group
Wearables/sensors and ePsycHeart App
• Intervention group
Wearables/sensors and ePsycHeart App and eHealtHeart

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra-patient assessment of major adverse cardiac events (MACEs)	Angina pectoris; Acute myocardial infarction; Major ventricular arrhythmias; Pacemaker implantation; Acute heart failure (New York Heart Association (NYHA) class 4); Acute ischemic brain disease with neurological persistence evidence; Severe hypertension requiring treatment with Angiotensin-converting enzyme (ACE) and or beta blockers.	12 months
Secondary	Intra-patient assessment of plasma Troponin I	Intra-patient assessment of plasma Troponin I during follow up and association/agreement with LVEF	12 months
Secondary	Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation	Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation	12 months
Secondary	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	12 months
Secondary	Number of Cardiovascular death in the two arms	Number of Cardiovascular death in the two arms	12 months
Secondary	Number of Non-cardiovascular death in the two arms	Number of Non-cardiovascular death in the two arms	12 months
Secondary	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)	12 months
Secondary	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).	12 months