Early-stage Breast CancerCardioProtExNCT05467111
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
A study testing Acute Exercise in people with Early-stage Breast Cancer, run by Technical University of Madrid at 1 site in Spain.
Trial summary
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Acute Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2023to Oct 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with non-metastatic breast cancer not previously treated.
- Scheduled to receive neoadjuvant doxorubicin chemotherapy.
- Receive the oncologist´s approval for the practice of exercise.
- Acceptance of randomization.
- To sign an informed consent form before starting any measurement or procedure related to the project.
Who cannot join
- Patients who receive initial surgery and who are not going to receive neoadjuvant treatment.
- Contraindications to perform stress tests following the recommendations of the American Thoracic Society.
- Pre-existing cardiovascular disease.
- Body mass index (BMI) > 35 kg/m2.
- Diabetes mellitus.
- Renal disease.
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- Severe anemia.
- Pregnacy.
- Current smoking status.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
"Ramón y Cajal" Hospital
Madrid, 28034
María Alonso, +34 678942096, maria.alonsod@alumnos.upm.es
María Fernández Abad
About this study
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP).
Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Acute Exercise
- Keywords
- Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity
- Medical subject headings
- Breast Neoplasms, Motor Activity, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute ExerciseOther
Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines, as aerobic exercise, strength training or combined training) 24-48 hours prior to each cycle of anthracyclines.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines. Receives: Other: Acute Exercise |
| Control | No intervention | Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
Biomarker of cardiac injury value in blood tests
Measured: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Secondary outcomes (3)
Cardiac Troponin I
Biomarker of cardiac injury value in blood tests
Measured: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Blood Pressure
Resting blood pressure assesed by sphyngomanometer
Measured: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular systolic function quantified by transthoracic echocardiography
Measured: 0-14 days prior to the first treatment ( according to the usual clinical practice) and in the follow-up period (6 months after completion of the anthracycline treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start23 Jan 2023
- Primary completionApr 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro San Juan Ferrer, Technical University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467111
- Sponsor's protocol ID
- DATOS-20220624-ASJF-Efecto car
- Acronym
- CardioProtEx
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05467111
- Acronym / sponsor ID
- CardioProtEx / DATOS-20220624-ASJF-Efecto car
- Conditions
- Early-stage Breast Cancer
- Keywords
- Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Jul 2022 (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.
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP).
Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Acute ExercisePatients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines. |
| Control | No intervention | –Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Woman with non-metastatic breast cancer not previously treated.
- Scheduled to receive neoadjuvant doxorubicin chemotherapy.
- Receive the oncologist´s approval for the practice of exercise.
- Acceptance of randomization.
- To sign an informed consent form before starting any measurement or procedure related to the project.
Key exclusion criteria (9 listed)
- Patients who receive initial surgery and who are not going to receive neoadjuvant treatment.
- Contraindications to perform stress tests following the recommendations of the American Thoracic Society.
- Pre-existing cardiovascular disease.
- Body mass index (BMI) > 35 kg/m2.
- Diabetes mellitus.
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 |
|---|---|---|
| Acute ExercisePatients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines, as aerobic exercise, strength training or combined training) 24-48 hours prior to each cycle of anthracyclines. | Other | Exercise |
Primary outcome
NT-proBNP
Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Biomarker of cardiac injury value in blood tests
3 secondary outcomes
Cardiac Troponin I
Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Blood Pressure
Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Left Ventricular Ejection Fraction (LVEF)
Time frame: 0-14 days prior to the first treatment ( according to the usual clinical practice) and in the follow-up period (6 months after completion of the anthracycline treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Exercise in people with Early-stage Breast Cancer, run by Technical University of Madrid 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Alonso (+ 34 678942096, maria.alonsod@alumnos.upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.