Ovarian suppression combined with exercise and nutrition for breast cancer treatment

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

This study is testing whether a program that combines exercise, healthy eating, and emotional support can help premenopausal women with localized breast cancer manage their weight and improve their overall health while they undergo ovarian suppression therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Universidad Pontificia Comillas (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT06727487 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18 to 45 with localized breast cancer expressing estrogen and/or progesterone receptors who are currently receiving ovarian suppression therapy.

Not a fit: Patients with medical contraindications to physical exercise or those with active neoplastic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help improve body composition and overall health outcomes for women undergoing treatment for breast cancer.

How similar studies have performed: While similar interventions have shown promise in improving outcomes for breast cancer patients, this specific combination of approaches is relatively novel.

Eligibility criteria

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 this trial is running

Madrid and 1 other locations

• 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

Conditions: Breast Neoplasms, Physical Exercise, Nutritional advice, Psico-oncological support, Patient Report Outcomes