Cardioprotective Effect of Acute Exercise in Breast Cancer Patients (NCT05467111) | Clinical Trial Compass
UnknownNot Applicable
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
Spain40 participantsStarted 2023-01-23
Plain-language 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 (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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Severe anemia.
* Pregnacy.
* Current smoking status.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NT-proBNP
Timeframe: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment