Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorEuropean University Miguel de Cervantes
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Prehabilitation: Exercise and nutrition
Other interventionPrehabilitation phase: * Exercise training: During a 2-4-week prehabilitation phase, participants will perform supervised concurrent training sessions, including a high-intensity circuit of multi-joint resistance exercises and a high-intensity interval training. * Nutrition: A dietitian will implement a 2-4-week structured plan providing 25-30 kcal/kg/day, 1.2-1.5 g protein/kg/day, at least 150 g carbohydrates/day, and ≥5 meals/day. The plan will also ensure adequate vitamins and antioxidants and include guidance on portion distribution to meet recommended intake of all food groups. Neoadjuvant or adjuvant treatment phase: * Exercise training: After treatment begins, participants will follow a home-based training plan during treatment: 3 weekly elastic-band resistance sessions + ≥150 min/week aerobic exercise. First week supervised; then remote follow-up. * Nutrition: The participants will continue the guidelines provided during the prehabilitation phase.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Exercise and nutrition groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cardiorespiratory fitness (peak oxygen consumption): Direct method
The change in peak oxygen consumption (ml·kg-¹·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Time frame
Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.2
Cardiorespiratory fitness: Indirect method (30-Second Sit-to-Stand Test)
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Time frame
Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).3
Cardiorespiratory fitness: Indirect method (Six-Minute Walk Test)
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Time frame
Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).Secondary outcomes
1
Handgrip strength
The change in handgrip strength (in kilograms) will be assessed. The Jamar® Smart hand dynamometer (Patterson Medical Ltd., Sammons Preston, Nottinghamshire, UK) will be used to assess handgrip strength.
Time frame
Baseline; up to 1 week after prehabilitation; 1 week post-surgery, up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)2
Upper-body maximal voluntary isometric contraction: Chest press
The change in the chest press maximal voluntary isometric contraction (MVIC) (in Newton) will be assessed. MVIC will be evaluated with the Chronojump Force Sensor Kit (Chronojump Boscosystems®, Barcelona, Spain) and the open-source Chronojump software 2.30.0 for Windows. Upper-body MVIC will be assessed using the unilateral chest press exercise.
Time frame
Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)3
Lower-body maximal voluntary isometric contraction: Squat
The change in the squat maximal voluntary isometric contraction (MVIC) (in Newton) will be assessed. MVIC will be evaluated with the Chronojump Force Sensor Kit (Chronojump Boscosystems®, Barcelona, Spain) and the open-source Chronojump software 2.30.0 for Windows. Lower-body MVIC will be assessed during the 90º knee-flexion squat test.
Time frame
Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).4
Inflammation-related proteins
The change in the levels of inflammation-related proteins (in Normalized Protein eXpression levels, an arbitrary unit on a log2 scale) in plasma will be assessed. Venous samples will be collected. Plasma samples will be sent with dry ice to the Cobiomic laboratory of Olink ® Proteomics, Córdoba, Spain, which will analyze 1 μL of each sample using the Olink ® Target 96 Inflammation panel (Cobiomic Bioscience, S.L; https://olink.com/products/olink-target-96).
Time frame
Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.Sponsors and contacts
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Source ClinicalTrials.gov