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OvS Breast: Ovarian Suppression in Breast Cancer Interventions
Sponsor: Universidad Pontificia Comillas
Summary
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.
Official title: OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-11-15
Completion Date
2025-12-15
Last Updated
2024-12-11
Healthy Volunteers
No
Conditions
Interventions
Basic recommendations
Daily basis activity counseling by WHO recommendations
Physical exercise
A complete program of active physical exercise of medium and high intensity
Nutritional advice
A complete program of nutritional counseling
Psycho-oncological support
A program related with a patient Psycho-oncological follow-up
Locations (2)
Universidad Pontificia Comillas
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain