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Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Recoletas Campo Grande
RECRUITING
Valladolid
Miguel de Cervantes European University
RECRUITING
Valladolid
Contact Information
Primary
Alejandro Santos Lozano, PhD
asantos@uemc.es
+34 983001000
Backup
Celia García Chico, PhD
cgarciac@uemc.es
+34 983001000
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2029-05
Participants
Target number of participants: 66
Treatments
Experimental: Exercise and nutrition group
Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period.
No_intervention: Control group
Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition.
Related Therapeutic Areas
Sponsors
Leads: European University Miguel de Cervantes

This content was sourced from clinicaltrials.gov