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RECRUITING
NCT06727487
NA

OvS Breast: Ovarian Suppression in Breast Cancer Interventions

Sponsor: Universidad Pontificia Comillas

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

Basic recommendations

Daily basis activity counseling by WHO recommendations

BEHAVIORAL

Physical exercise

A complete program of active physical exercise of medium and high intensity

BEHAVIORAL

Nutritional advice

A complete program of nutritional counseling

BEHAVIORAL

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