RecruitingNot ApplicableNCT06727487

OvS Breast: Ovarian Suppression in Breast Cancer Interventions

OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project

Sponsor

Universidad Pontificia Comillas

Enrollment

30 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

Women who have reached the age of majority and up to 45 years of age.
Premenopausal status is defined clinically as a patient who maintains menstruation prior to the start of chemotherapy treatment if this has taken place.
Confirmed histological diagnosis of infiltrating breast carcinoma with expression of ER and/or RP stage I to III.
Loco-regional treatment with surgery and radiotherapy, if any, completed.
Adjuvant treatment with drugs that suppress ovarian function (aLHRH) is ongoing and expected to be maintained for at least 4 months at the beginning of the study.
Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-1.
Ability to understand and agree to the Informed Consent in writing.

Exclusion Criteria5

Presence of medical contraindications to perform physical exercise.
Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.
Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.
Pregnancy or breastfeeding.
Alcohol or other drug abuse (excluding smoking).