Randomized pilot study of an individualized multimodal exercise, nutrition, and behavior intervention in breast cancer patients treated with ovarian function suppression: protocol proposal for The OvS Breast ENBI Project

Abstract

El estudio propone un ensayo piloto aleatorizado para evaluar la factibilidad y efectos preliminares de una intervención multimodal individualizada en pacientes premenopáusicas con cáncer de mama receptor hormonal positivo sometidas a supresión de la función ovárica (OFS). La intervención, de 12 semanas, combina ejercicio físico supervisado, asesoramiento nutricional y apoyo psicooncológico, comparada con las recomendaciones de estilo de vida saludable de la OMS. Los resultados principales se centran en los cambios en peso y composición corporal, mientras que los secundarios incluyen capacidad cardiorrespiratoria, fuerza muscular, bienestar psicológico y marcadores inflamatorios. Se reclutarán 30 pacientes en el Hospital General Universitario Gregorio Marañón. Este protocolo destaca un enfoque personalizado, integral y seguro, orientado a mejorar la calidad de vida y reducir efectos adversos asociados al tratamiento hormonal en mujeres jóvenes con cáncer de mama.

Introduction: Breast cancer (BC) is the most common malignancy among women in Spain and worldwide. Ovarian function suppression (OFS) is recommended as an adjuvant strategy for high-risk hormone receptor (HR)-positive premenopausal BC patients. However, OFS is associated with unfavorable changes in body composition, weight gain, and adverse cardiorespiratory and emotional effects. Multimodal, individualized interventions integrating nutrition, exercise, and psycho-oncological support have demonstrated safety and efficacy in promoting healthy body composition, weight control, and cardiorespiratory fitness (CRF). This study aims to evaluate the impact of a personalized multicomponent intervention in premenopausal BC patients receiving adjuvant OFS. Methods: We present the ENBI project protocol as a single-center, open-label, 2:1 randomized pilot study designed to assess the effects of a 12-week individualized program (nutrition, exercise, and psycho-oncological support) versus WHO healthy lifestyle recommendations.