OvS Breast: Ovarian Suppression in Breast Cancer Interventions

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.

NCT Number	NCT06727487
Lead Sponsor	Universidad Pontificia Comillas Collaborators: Hospital General Universitario Gregorio Marañon, San Juan de Dios Foundation
Conditions	Breast Neoplasms
Enrollment	30 participants
Start Date	2024-11-15
Primary Completion	2025-04-15 (estimated)
Study Completion	2025-12-15 (estimated)
Updated on ClinicalTrials.gov	2024-12-11