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.
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
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:
- Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group)
- 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)
- Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.
- Conditions
- Cardiotoxicity, Cardiac Rehabilitation
- 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 group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Patients enrolled in the integrated exercise-based cardiac rehabilitation program (centre-based or telematic) Receives: Other: Cardiac rehabilitation |
| Conventional management | No intervention | Patients with conventional management and physical activity recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted28 May 2019
- Study start1 Aug 2018
- Primary completion30 Mar 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Carlos Peña Gil, Hospital Clinico Universitario de Santiago
- Investigators
- Amparo Martínez Monzonís, MD, PhD, Principal investigator, Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CVCarlos Peña Gil, MD, PhD, Principal investigator, Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CVJosé Ramón González Juanatey, MD, PhD, Study director, Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV
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 35819522Diaz-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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03964142
- Acronym / sponsor ID
- ONCORE / PI17/01687
- Conditions
- Cardiotoxicity, Cardiac Rehabilitation
- Keywords
- Chemotherapy, Anthracyclines, Trastuzumab, Pertuzumab, Antibodies, Monoclonal, Humanized, Breast Cancer, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group)
- 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)
- Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Other: Cardiac rehabilitationPatients enrolled in the integrated exercise-based cardiac rehabilitation program (centre-based or telematic) |
| Conventional management | No intervention | –Patients with conventional management and physical activity recommendation |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationIntegrated 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). | Other | Cardiac Rehabilitation |
Primary outcome
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
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
23 secondary outcomes
Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Baseline and at the end of the study at an average of 18 months
Change in upper limb strength measured by dynamometry (kg)
Time frame: Baseline and at the end of the study at an average of 18 months
Change in shoulder pain and disability assessed by the SPADI (shoulder pain and disability index (SPADI) questionnaire
Time frame: Baseline and at the end of the study at an average of 18 months
Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors
Time frame: Baseline and at the end of the study at an average of 18 months
Change in anthropometric parameters: height in cm
Time frame: Baseline and at the end of the study at an average of 18 months
Change in anthropometric parameters: weight in kg
Time frame: Baseline and at the end of the study at an average of 18 months
Change in anthropometric parameters: body mass index (BMI) in kg/m^2
Time frame: Baseline and at the end of the study at an average of 18 months
Change in anthropometric parameters: abdominal circumference in cm
Time frame: Baseline and at the end of the study at an average of 18 months
Change in resting heart rate measured by pulse oximetry (beats per min)
Time frame: Baseline and at the end of the study at an average of 18 months
Change in resting blood pressure (mmHg) measured by sphygmomanometer
Time frame: Baseline and at the end of the study at an average of 18 months
Change in biomarkers NT-ProBNP
Time frame: Baseline and at the end of the study at an average of 18 months
Change in biomarkers: troponin
Time frame: Baseline and at the end of the study at an average of 18 months
Change in biomarkers: haemoglobin
Time frame: Baseline and at the end of the study at an average of 18 months
Change in dietary pattern as assessed by the PREDIMED (PREvención con DIeta MEDiterránea) questionnaire
Time frame: Baseline and at the end of the study at an average of 18 months
Change in the score for depression assessed by Zigmond and Snaith questionnaire to rate anxiety and depression
Time frame: 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
Change in the score for anxiety assessed by the Zigmond and Snaith questionnaire to rate depression and anxiety
Time frame: Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention group
Change in physical activity (minutes of dedicated physical activity)
Time frame: Baseline and at study completion at an average of 18 months
Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)
Time frame: Baseline and at study completion at an average of 18 months
Change in lymphedema assessed by perimeter of the upper limb by cirtometry (cm), stage and grade
Time frame: Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 35819522Diaz-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.
- Derived from this study: PubMed 33827450Diaz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amparo Martínez Monzonís, MD, PhD principal investigator
Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV
Carlos Peña Gil, MD, PhD principal investigator
Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV
José Ramón González Juanatey, MD, PhD study director
Cardiology Department, Hospital Clínico Universitario de Santiago, CIBER-CV
1 site in 1 country: see every site and its status.
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.