Antineoplastic Agents, Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Cardiotoxicity, Elderly
Conditions
Keywords
Cardiotoxicity, Elderly, Antineoplastic agents, Cardiovascular monitoring, Cardioprotection, Cardio-oncology, Chemically-Induced Disorders, Radiation Injuries, Drug-Related Side Effects and Adverse Reactions., Primary prevention, Secondary prevention., Mortality
Brief summary
The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. The incidence of primary and secondary outcomes will be measured at 2 and 5 years
Interventions
OTHERIntensive cardiovascular monitoring
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.
OTHERNo intervention
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria
Sponsors
Instituto de Investigación Biomédica de Salamanca
Instituto de Salud Carlos III
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 65 years old * Expected survival \>1 year * Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma * Signature on the informed consent
Exclusion criteria
* Patients included in clinical trials will be excluded if they interfere with the CARTIER follow-up protocol. If they do not interfere they can be included * Patients who had received previous potentially cardiotoxic anticancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Two (mid-term analysis) and five years of follow-up | Cumulative incidence of all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | Two and five years of follow-up | Cumulative incidence of cardiovascular mortality |
| Hospitalization | Two and five years of follow-up | Cumulative incidence of hospitalization |
| Oncological mortality | Two and five years of follow-up | Cumulative incidence of oncological mortality |
| Hospitalization/emergency cancer cause | Two and five years of follow-up | Cumulative incidence of hospitalization and/or emergency care for cancer cause |
| Tumor recurrence or progression | Two and five years of follow-up | Incidence of tumoral recurrence or progression |
| Hospitalization/emergency cardiovascular cause | Two and five years of follow-up | Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause |
Countries
Spain
Contacts
Primary ContactPedro L Sánchez, Ph. D.
Backup ContactAna Martín-García, Ph. D.
Outcome results
None listed