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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Gabriella Pravettoni
gabriella.pravettoni@ieo.it
+39 02 57489.731
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 736
Treatments
Control group
Wearables/sensors and ePsycHeart App
Intervention group
Wearables/sensors and ePsycHeart App and eHealtHeart
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov