Prehabilitation plus ongoing exercise and nutrition support for women with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, two-arm randomized controlled trial enrolling 66 newly diagnosed women with stage 0–III breast cancer in Valladolid, Spain. Participants are randomized to a supervised prehabilitation program combining high-intensity concurrent training and personalized nutritional guidelines or to a supportive care program emphasizing home-based exercise and nutritional guidance throughout treatment. The study will measure functional outcomes, clinical status, quality of life, and treatment tolerance (including relative dose intensity) across the cancer treatment continuum. Recruitment occurs immediately after diagnosis for patients scheduled for surgery, neoadjuvant systemic therapy, or radiotherapy, with supervised sessions at local hospital and university facilities and additional home-based follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Recoletas Campo Grande
  Valladolid, Valladolid, Spain Recruiting
• Miguel de Cervantes European University
  Valladolid, Valladolid, Spain Recruiting

Study contacts

• Principal investigator: Alejandro Santos Lozano, PhD — Miguel de Cervantes European University
• Study coordinator: Alejandro Santos Lozano, PhD
• Email: asantos@uemc.es
• Phone: +34 983001000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.