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OvS Breast: Ovarian Suppression in Breast Cancer Interventions

NCT06727487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

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

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • San Juan de Dios Foundation

    collaborator UNKNOWN

  • Universidad Pontificia Comillas

    lead OTHER

Principal Investigators

  • Julio C de la Torre, Ph.D · Universidad Pontificia Comillas

  • Blanca Herrero López, MD · Hospital Universitario Gregorio Marañón

  • Soraya Casla Barrio, Ph.D · Comillas Pontifical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-04-15
Completion
2025-12-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06727487 on ClinicalTrials.gov