Exercise-based Cardiac Rehabilitation for the Prevention of Breast Cancer Chemotherapy-induced Cardiotoxicity

NCT03964142 | Completed

• 1 other identifier: PI17/01687
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants will be randomly allocated to cardiac rehabilitation (intervention group) or conventional management with physical exercise recommendation (control group).

Conditions

Cardiotoxicity; Cardiac Rehabilitation

Keywords

Chemotherapy; Anthracyclines; Trastuzumab; Pertuzumab; Antibodies, Monoclonal, Humanized; Breast Cancer; Exercise therapy

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography

  Fall of 10 absolute percentage points of left ventricular ejection fraction with final value below 53% or global longitudinal strain fall \>15% with respect to baseline

  Baseline to every 3 months through study completion, at the end of the study at an average of 18 months, and every year after study completion up to a maximum of 5 years

Secondary Outcomes (23)

• Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire

  Baseline and at the end of the study at an average of 18 months

• Change in tolerance to chemotherapy: number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study

  Every 3 months during study completion and at the end of the study at an average of 18 months

• Change in global functional capacity assessed by conventional ergometry, cardiopulmonary exercise testing (CPET) or the 6-minute walking test (6MWT).

  Baseline and at the end of the study at an average of 18 months

• Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test

  Baseline and at the end of the study at an average of 18 months

• Change in shoulder functional capacity assessed by range of degrees in shoulder movement by goniometry

  Baseline and at the end of the study at an average of 18 months

Other Outcomes (4)

• Adherence and compliance to cardiac rehabilitation program (intervention group) assessed by number of training sessions attended/ number of sessions planned

  At the end of the cardiac rehabilitation program at an average of 12 to 15 months

• Security of the cardiac rehabilitation program assessed by number of adverse events during training (intervention group)

  At the end of the cardiac rehabilitation program at an average of 12 to 15 months

• Changes in expectations regarding the cardiac rehabilitation program assessed by a questionnaire (intervention group)

  Baseline and at the end of the cardiac rehabilitation program at an average of 12 to 15 months

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

Patients enrolled in the integrated exercise-based cardiac rehabilitation program (centre-based or telematic)

Other: Cardiac rehabilitation

Conventional management

NO INTERVENTION

Patients with conventional management and physical activity recommendation

Interventions

Cardiac rehabilitation OTHER

Integrated cardiac rehabilitation program that includes supervised exercise training\*. \* Due to the COVID-19 pandemic, supervised physical exercise training had to be conducted telematically (through live guided training sessions conducted online, with the same design, frequency, and dosage of exercise).

Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First diagnosis of breast cancer at early stages (I, II, III)
• Treatment with anthracyclines and / or anti-HER-2 antibodies (trastuzumab and / or pertuzumab)
• Possibility of completing a cardiac rehabilitation program (centre-based or telematic) and programmed visits.
• Providing written informed consent.

You may not qualify if:

• Patients with previous history of heart disease or heart failure.
• Left ventricular dysfunction (left ventricular ejection fraction \<53%) at baseline.
• Metastatic disease.
• Patients carrying an implantable cardioverter defibrillator.
• Patients with physical or mental limitation to carry out an exercise program.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Related Publications (2)

• Diaz-Balboa E, Gonzalez-Salvado V, Rodriguez-Romero B, Martinez-Monzonis A, Pedreira-Perez M, Cuesta-Vargas AI, Lopez-Lopez R, Gonzalez-Juanatey JR, Pena-Gil C. 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. 2022 Oct;30(10):8251-8260. doi: 10.1007/s00520-022-07268-z. Epub 2022 Jul 11.

  PMID: 35819522 DERIVED

• Diaz-Balboa E, Gonzalez-Salvado V, Rodriguez-Romero B, Martinez-Monzonis A, Pedreira-Perez M, Palacios-Ozores P, Lopez-Lopez R, Pena-Gil C, Gonzalez-Juanatey JR. A randomized trial to evaluate the impact of exercise-based cardiac rehabilitation for the prevention of chemotherapy-induced cardiotoxicity in patients with breast cancer: ONCORE study protocol. BMC Cardiovasc Disord. 2021 Apr 7;21(1):165. doi: 10.1186/s12872-021-01970-2.

  PMID: 33827450 DERIVED

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Amparo Martínez Monzonís, MD, PhD

  Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV

  PRINCIPAL INVESTIGATOR

• Carlos Peña Gil, MD, PhD

  Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV

  PRINCIPAL INVESTIGATOR

• José Ramón González Juanatey, MD, PhD

  Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Cardiac Rehabilitation Unit, Cardiology Department

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: May 28, 2019
• Study Start: August 1, 2018
• Primary Completion: March 30, 2022
• Study Completion: January 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

ES (1)