Cardio-Oncology Rehabilitation Care Process

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise-based cardio-oncology rehabilitation: Within the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises.

Study summary

The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).

Eligibility

Primary outcome measure(s)

• Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  Fall of 10 absolute percentage points of left ventricular ejection fraction from baseline or with final value below 53% or global longitudinal strain fall \>15% with respect to baseline
• Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  cTnI/T\>percentil 99, BNP≥35 pg/mL, NT-proBNP≥125 pg/mL
• Decrease in functional capacity assessed by estimated VO2peak — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
  To estimate VO2peak, the ONCORE equation developed in the following article is used: Díaz-Balboa, E., González-Salvado, V., Rodríguez-Romero, B. et al. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer 30, 8251-8260 (2022). https://doi.org/10.1007/s00520-022-07268-z
• Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
• Changes in fasting blood glucose — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  Value of fasting blood glucose (mg/dL) in blood tests
• Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  Value of LDL \>160 mg/dL or CT\> 200 mg/dL in blood tests
• Change in haemoglobin — Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
  Value of haemoglobin (g/dL) in blood tests
• Significant cardiovascular and non-cardiovascular adverse effects during treatment. — Date of the event throughout the study.
  number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions.

Trial sites (1)

More Hospital Clinico Universitario de Santiago trials in Spain

Other trials for the same condition