About this trial
The goal of this clinical trial is to compare a combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized BC with ER and/or PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment.
The study's primary objectives are to evaluate the impact of the combined intervention on weight reduction and favorable modification of body composition in terms of reduction in body fat and increase in lean mass.
The secondary objectives aim to evaluate the impact of the combined intervention program on CRF, heart rate (HR), capillary lactate levels, upper and lower body strength, physical functionality, and patient-reported outcomes (PROs). (exercise level, asthenia, self-perception, anxiety and depression), blood count and biochemistry values that could be modified, nutritional situation, and side effects of treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who have reached the age of majority and up to 45 years of age.
Premenopausal status is defined clinically as a patient who maintains menstruation prior to the start of chemotherapy treatment if this has taken place.
Confirmed histological diagnosis of infiltrating breast carcinoma with expression of ER and/or RP stage I to III.
Loco-regional treatment with surgery and radiotherapy, if any, completed.
Disqualifiers
Presence of medical contraindications to perform physical exercise.
Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.
Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.
Pregnancy or breastfeeding.
Trial design
Crossover
Treatments tested in this trial
Basic recommendations
BehavioralDaily basis activity counseling by WHO recommendations
Physical exercise
BehavioralA complete program of active physical exercise of medium and high intensity
Nutritional advice
BehavioralA complete program of nutritional counseling
Psycho-oncological support
BehavioralA program related with a patient Psycho-oncological follow-up
Treatment groups
Trial outcomes
Primary outcomes
Combined intervention evaluation on weight control
A combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized breast cancer expressing estrogen receptors and progesterone receptors who receive adjuvant treatment. The psycho-oncological intervention program aims to increase motivation to adhere to the physical exercise program and nutritional recommendations and maintain long-term healthy lifestyle habits.
Combined intervention evaluation in body composition
The variables weight, kilograms, fat mass, lean mass, and extracellular water will be obtained with the Tanita BC-601 Gold scale, including an impedance meter. The height, waist, and hip circumferences will be obtained with a tape measure. These measurements are necessary for calculating the BMI and the waist-high index (measure in centimeters). Weight and height will be combined to report BMI in kg/m\^2 Units of measure: weight in kilograms, height in meters.
Secondary outcomes
Improve Quality of Life on Patient Report Outcomes
To evaluate the impact of the combined intervention program on patient-reported outcomes (PROs) (exercise level , asthenia, self-perception, anxiety and depression). The combination of several validated tests allows us to establish a balanced measure with the multi-professional approaches that care for the patient. Patient Reported Outcomes (PROs): These will be assessed and collected by completing validated questionnaires for this purpose. * Quality of life: EuroQoL-5D questionnaire * Fatigue: FACIT-Fatigue questionnaire * Level of physical activity: International Physical Activity Questionnaire (IPAQ) * Self-perception/self-esteem: Rosemberg Self-Esteem Scale * Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS)
Nutritional Status follow-up
Nutritional status: It will be assessed using the following tools at the beginning, 6 weeks after the start of the intervention and at the end of the 12 weeks.The combination of several validated tests allows us to establish a balanced measure of the specific situation in each patient. * 3-day nutritional record * Predimed Mediterranean diet adherence questionnaire * WCRF/AICR recommendations compliance scale
Psycho-oncological assessment
Psycho-oncological assessment: It will be assessed with the following questionnaires that the patient will complete at the beginning and the end of the 12 weeks of intervention. The combination of several validated tests allows us to establish a measure that relates the emotional state with the variables of physical exercise The PANAS affectivity scale will have an additional intermediate evaluation six weeks after the start of the intervention. * PANAS affectivity scale * Transtheoretical model of change in physical exercise (CMTCEJ) questionnaire. * MOS social support questionnaire
Cardiorespiratory Fitness: Evaluation of physical activity performance
Evaluation of physical activity performance thought: -Cardiorespiratory fitness (CRF): The Bruce test will be evaluated to determine the maximum oxygen consumption (VO2max, milliliters/kilogram/minute). -Cardiac variability (HR at rest and maximum (beats/minute)): It will be measured with an HR receiver before the Bruce test (at rest) and at the time of finishing it (maximum effort)
Sponsors and contacts
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Universidad Pontificia Comillas
Lead sponsor
Hospital General Universitario Gregorio Marañon
Collaborator
San Juan de Dios Foundation
Collaborator