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

Plain Language Summary

Simplified for easier understanding

This study is examining the effects of exercise on the heart, bones, and overall health in premenopausal women with breast cancer who are receiving ovarian suppression therapy (medication that stops the ovaries from producing estrogen). These treatments can cause side effects like bone loss and heart changes that exercise might help address. **You may be eligible if...** - You are a woman who has reached the legal age of adulthood and are up to 45 years old - You are premenopausal (still had periods before starting chemotherapy) - You have a confirmed diagnosis of stage I to III hormone receptor-positive breast cancer - You have completed local treatment (surgery and radiation, if applicable) - You are currently on ovarian suppression therapy (LHRH agonist) and expect to continue for at least 4 more months - You are in good general health (able to perform daily activities without difficulty) **You may NOT be eligible if...** - You have a medical condition that prevents you from exercising safely - You meet criteria that prevent a cardiovascular fitness test - You have metastatic breast cancer or another active cancer - You are pregnant or breastfeeding - You have an alcohol or substance use problem Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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