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CardiotoxicityONCORENCT03964142

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

A study testing Cardiac rehabilitation in people with Cardiotoxicity and Cardiac Rehabilitation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years, women only
Conditions the study is for
Cardiotoxicity, Cardiac Rehabilitation
What is being tested?
Cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteSpain
Study dates
1 Aug 2018to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

Other trials in Spain

About this study

Official title: Randomized Controlled Trial on Comprehensive Exercise-based Cardiac Rehabilitation Programs for the Prevention of Anthracyclines and/or Anti-HER2 Antibodies-induced Cardiotoxicity in Breast Cancer

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).

Read the detailed description

Cardiovascular toxicity caused by chemotherapy is the leading cause of death in patients who survive cancer. Physical exercise during chemotherapy has shown to improve quality of life and decrease the risk of death. The objective of this project is to determine whether an intervention through a comprehensive cardiac rehabilitation program including supervised physical exercise is able to prevent anthracyclines and / or anti-HER-2 antibodies-induced cardiotoxicity in women with breast cancer.

For this purpose, the investigators intend to conduct a randomized controlled study including female patients managed under the same cardiotoxicity prevention protocol (clinical, laboratory and echocardiographic follow-up assessment). Patients will be randomized to a non-pharmacological intervention (participation in a multidisciplinary cardiac rehabilitation program with supervised exercise training) or control (conventional management and physical activity recommendation)*.

The investigators hypothesize that a cardiac rehabilitation program may limit chemotherapy-induced cardiotoxicity in women with breast cancer, improve cardiac remodeling assessed by echocardiography and enhance their global cardiovascular risk profile to a greater extent, compared to control group.

  • OF NOTE: Due to the COVID-19 pandemics, several modifications to the original protocol were introduced for safety reasons or motivated by the health situation, namely:
  1. Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group)
  2. Secondary outcome 4: Change in functional capacity assessed by conventional ergometry or cardiopulmonary exercise test OR the 6-minute walking test (metabolic equivalents: METs or peak oxygen consumption: VO2)
  3. Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.
Being tested
Cardiac rehabilitation
Keywords
Chemotherapy, Anthracyclines, Trastuzumab, Pertuzumab, Antibodies, Monoclonal, Humanized, Breast Cancer, Exercise therapy
Medical subject headings
Cardiotoxicity, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac rehabilitationOther

    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).
Study groups in NCT03964142
Study groupRoleWhat they receive
Cardiac RehabilitationExperimentalPatients enrolled in the integrated exercise-based cardiac rehabilitation program (centre-based or telematic)
Receives: Other: Cardiac rehabilitation
Conventional managementNo interventionPatients with conventional management and physical activity recommendation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst posible result) to a maximum of 146 (best possible result).

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

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

    Significant cardiovascular and non-cardiovascular adverse effects during treatment, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions

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

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

    Change in functional capacity assessed by conventional ergometry, cardiopulmonary exercise test or the 6-minute walking test (6MWT) (metabolic equivalents: METs or peak oxygen consumption: VO2) * .

    *Due to COVID-19 pandemic, participants' assessment with CPET had to be stopped for safety concerns. In such cases, functional capacity was estimated from the maximum work rate in the 6-minute walking test (6MWT). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes, which is well correlated with VO2. The 6MWT has been proved to be valid and reliable for functional capacity assessment in the study population.

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

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

    Number of repetitions in the sit-to-stand test within 30 seconds

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

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

    Range of degrees in shoulder movement measured by goniometry

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

  6. Change in upper limb strength measured by dynamometry (kg)

    Kilograms by dynamometry of right and left upper limbs

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

  7. Change in shoulder pain and disability assessed by the SPADI (shoulder pain and disability index (SPADI) questionnaire

    Score achieved in the SPADI (shoulder pain and disability index) questionnaire. The pain dimension consists of five questions regarding the severity of an individual's pain, functional activities are assessed with eight questions. Each question may be scored from 0 to 10. Verbal anchors for the pain dimension are 'no pain at all' (0) and 'worst pain imaginable' (10) ,and those for the functional activities are 'no difficulty' (0) and 'so difficult it required help' (10). The scores from both dimensions are averaged to produce a total score ranging from 0 (best) to 100 (worst).

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

  8. Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors

    Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status

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

  9. Change in anthropometric parameters: height in cm

    Height measured in cm

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

  10. Change in anthropometric parameters: weight in kg

    Weight measured in kg

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

  11. Change in anthropometric parameters: body mass index (BMI) in kg/m^2

    Weight and height will be combined to report BMI in kg/m^2

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

  12. Change in anthropometric parameters: abdominal circumference in cm

    Abdominal perimeter measured with a tape measure in cm

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

  13. Change in resting heart rate measured by pulse oximetry (beats per min)

    Resting heart rate by pulse oximetry (beats per min)

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

  14. Change in resting blood pressure (mmHg) measured by sphygmomanometer

    Resting blood pressure by sphyngomanometer in mmHg

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

  15. Change in biomarkers NT-ProBNP

    Value of NT-ProBNP(pg/mL) in blood tests

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

  16. Change in biomarkers: troponin

    Value of troponin I (ng/mL) in blood tests

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

  17. Change in biomarkers: haemoglobin

    Value of haemoglobin (g/dL) in blood tests

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

  18. Change in dietary pattern as assessed by the PREDIMED (PREvención con DIeta MEDiterránea) questionnaire

    Validated questionnaire to assess adherence to Mediterranean diet, including 14 questions regarding dietary habits, rated with 0 or +1 points. Global score is calculated by summing points and ranges from 0 to 14, with higher score representing higher adherence.

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

  19. Change in the score for depression assessed by Zigmond and Snaith questionnaire to rate anxiety and depression

    Score achieved in the depression subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Depression scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater depression. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).

    Measured: Baseline and at study completion at an average of 18 months, plus at the end of training (at an average of 12 to 15 months) in the intervention group

  20. Change in the score for anxiety assessed by the Zigmond and Snaith questionnaire to rate depression and anxiety

    Score achieved in the anxiety subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Anxiety scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater anxiety. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).

    Measured: Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention group

  21. Change in physical activity (minutes of dedicated physical activity)

    Minutes of In- and out-of-hospital dedicated physical activity

    Measured: Baseline and at study completion at an average of 18 months

  22. Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)

    Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).

    Measured: Baseline and at study completion at an average of 18 months

  23. Change in lymphedema assessed by perimeter of the upper limb by cirtometry (cm), stage and grade

    Perimeter of the upper limb by cirtometry (cm), stage and grade as defined by the Spanish Society of Rehabilitation and Physical Medicine

    Measured: Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start1 Aug 2018
  3. Primary completion30 Mar 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03964142
Sponsor's protocol ID
PI17/01687
Acronym
ONCORE
Status last verified
May 2023
First submitted
21 Feb 2019
Last updated
12 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35819522
  • 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.

    PubMed 33827450

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac rehabilitation in people with Cardiotoxicity and Cardiac Rehabilitation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03964142, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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