Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT07467824

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

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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