NCT07467824 Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
| NCT ID | NCT07467824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European University Miguel de Cervantes |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2026-04-14 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.
Eligibility Criteria
Inclusion Criteria: * Women who have a newly confirmed diagnosis of stage 0-III breast cancer. * Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-². * Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy. * Be able to perform supervised physical exercise, as determined by prior medical assessment. * Understand and voluntarily sign the written informed consent before the start of the study. Exclusion Criteria: * Women with a diagnosis of metastatic breast cancer. * Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure. * Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others. * Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise). * Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.
Contact & Investigator
Alejandro Santos Lozano, PhD
PRINCIPAL INVESTIGATOR
Miguel de Cervantes European University
Frequently Asked Questions
Who can join the NCT07467824 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07467824 currently recruiting?
Yes, NCT07467824 is actively recruiting participants. Contact the research team at asantos@uemc.es for enrollment information.
Where is the NCT07467824 trial being conducted?
This trial is being conducted at Valladolid, Spain, Valladolid, Spain.
Who is sponsoring the NCT07467824 clinical trial?
NCT07467824 is sponsored by European University Miguel de Cervantes. The principal investigator is Alejandro Santos Lozano, PhD at Miguel de Cervantes European University. The trial plans to enroll 66 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.