Prehabilitation plus ongoing exercise and nutrition support for women with breast cancer
Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial
This trial will test whether a short supervised pre-treatment program of high-intensity exercise and personalized nutrition followed by home-based exercise and dietary guidance helps newly diagnosed women with stage 0–III breast cancer recover better and tolerate treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | European University Miguel de Cervantes Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Valladolid, Valladolid and 1 other locations) |
| Trial ID | NCT07467824 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Newly diagnosed women aged 18–65 with stage 0–III breast cancer, BMI 18.5–35 kg/m2, medically cleared to perform supervised exercise and scheduled for surgery or neoadjuvant therapy are ideal candidates.
Not a fit: Women with metastatic disease, serious uncontrolled comorbidities, severe cardiovascular/respiratory/kidney failure, or major functional limitations that prevent exercise are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could reduce treatment-related complications and improve physical function, quality of life, and patients' ability to receive planned cancer therapy.
How similar studies have performed: Exercise and nutritional interventions have shown benefits for recovery and reduced complications in cancer care generally, but rigorous randomized data specifically on prehabilitation in early breast cancer remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valladolid, Valladolid and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.