Last reviewed · How we verify

NCT06727487: ENBI

OvS Breast: Ovarian Suppression in Breast Cancer Interventions

Recruiting now NA Last updated 11 December 2024
What this trial tests

NA trial testing Basic recommendations in Breast Neoplasms in 30 participants. Currently enrolling.

Timeline
15 November 2024
Primary endpoint
15 April 2025
15 December 2025

Quick facts

Lead sponsorUniversidad Pontificia Comillas
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment30
Start date15 November 2024
Primary completion15 April 2025
Estimated completion15 December 2025
Sites2 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universidad Pontificia Comillas

Who can join

Adults 18 to 45, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Herrero López B, Castellanos Montealegre M, Soulas C, Rufrancos BA, et al · · 2025 · cited 1× · PMID 41220947 · DOI 10.3389/fonc.2025.1622622

Verify or expand the search:

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

Other Universidad Pontificia Comillas trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06727487.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing