Actively Recruiting
Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
Led by European University Miguel de Cervantes · Updated on 2026-04-16
66
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a newly confirmed diagnosis of stage 0-III breast cancer
- Aged 18 to 65 years with a body mass index between 18.5 and 35 kg/m²
- Scheduled for surgery, neoadjuvant systemic treatment (chemotherapy or hormone therapy), or radiotherapy
- Able to perform supervised physical exercise as determined by prior medical evaluation
- Able to understand and provide written informed consent before starting the study
You will not qualify if you...
- Diagnosis of metastatic breast cancer
- Medical conditions that prevent physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure
- Serious uncontrolled medical problems like decompensated diabetes, severe hypertension, or acute psychiatric disorders
- Severe physical disabilities limiting the ability to perform planned exercise interventions
- Pregnancy, breastfeeding, likelihood of pregnancy during the trial, or inability to communicate
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Recoletas Campo Grande
Valladolid, Valladolid, Spain, 47007
Actively Recruiting
2
Miguel de Cervantes European University
Valladolid, Valladolid, Spain, 47012
Actively Recruiting
Research Team
A
Alejandro Santos Lozano, PhD
CONTACT
C
Celia García Chico, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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