The administration of breast cancer (BC) treatments is associated with various adverse events and acute toxicities that negatively affect molecular, functional, and clinical outcomes in patients with BC. Additionally, these adverse events may reduce treatment tolerance \[e.g., relative dose intensity (RDI)\], which has been shown to be associated with a worse prognosis in this population. Implementing a high-intensity concurrent training program and specific nutritional guidelines during this phase could reduce adverse treatment events and improve recovery. Likewise, including an unsupervised exercise program and nutritional guidelines during the rest of the cancer treatment may enhance the benefits obtained and improve different outcomes related to the patients' functionality, clinical status, quality of life, and treatment tolerance. Therefore, the aim of this study is to determine the effects of a prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on different outcomes in newly diagnosed women with BC.
This prospective, two-arm parallel randomized controlled trial will be conducted in Valladolid (Castilla y León, Spain). A total of 66 newly diagnosed women with BC will be recruited through medical and diagnostic appointments. Women will be recruited immediately after diagnosis and must be scheduled to receive neoadjuvant chemotherapy or hormone therapy, surgery, or radiation therapy. After completion of baseline study assessments, participants will be randomized to an experimental group or a control 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 during the medical treatment period. Participants in the control group will be asked to continue their usual care and will receive general recommendations for physical exercise and nutrition. Molecular (inflammation-related proteins, epinephrine and norepinephrine), functional (cardiorespiratory fitness, 30-Second Sit-to-Stand Test, Six-Minute Walk Test, handgrip strength and maximal voluntary isometric contraction), clinical (body composition, muscle thickness, and arm volume), and patient-reported (quality of life, upper-limb disability, fatigue, 24-hour nutritional record and food frequency questionnaire) outcomes will be assessed at baseline (week 0) and at various points during the scheduled cancer-associated treatments. Treatment tolerance (relative dose intensity, dose reduction, dose delay, early discontinuation of treatment, and number of patients completing the planned total dose) and treatment-related complications (seroma, infection; hematoma, wound dehiscence, persistent post-surgical pain, lymphedema, neuropathy, and thromboembolism) will be recorded throughout the continuum of treatments.
