Ovarian suppression combined with exercise and nutrition for breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a combined intervention that includes physical exercise, nutritional control, and individualized psycho-oncological support for premenopausal women with localized breast cancer who are undergoing ovarian suppression therapy. The primary focus is on achieving weight control and improving body composition by reducing body fat and increasing lean mass. Secondary objectives include assessing the impact of the intervention on various health metrics such as cardiorespiratory fitness, strength, and patient-reported outcomes related to quality of life. The study is designed to address the adverse effects of breast cancer treatments, particularly in younger women at high risk of relapse.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Universidad Pontificia Comillas
  Madrid, Spain Recruiting
• Hospital General Universitario Gregorio Marañón
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Blanca Herrero López, MD — Hospital Universitario Gregorio Marañón
• Study coordinator: Julio C de la Torre-Montero, Ph.D
• Email: juliodelatorre@comillas.edu
• Phone: +34678581021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.