Clinical trial · Interventional
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basic recommendations | Behavioral | — | UNRESOLVED |
| Nutritional advice | Behavioral | — | UNRESOLVED |
| Physical exercise | Behavioral | — | UNRESOLVED |
| Psycho-oncological support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1, control
- description
- Group 1/Control: patients will receive the basic recommendations on healthy lifestyle habits indicated by the World Health Organization (WHO) through audiovisual material that they will receive via email. An explanatory video and a document with WHO guidelines will be included (https://apps.who.int/iris/bitstream/handle/10665/337004/9789240014817-spa.pdf).
- interventionNames
- Behavioral: Basic recommendations
- type
- EXPERIMENTAL
- label
- Group 2, experimental
- description
- Group 2/ Exercise, nutrition, and psycho-oncological support: patients will carry out a cardiovascular and strength exercise program of moderate-high intensity at the facilities of the Exercise and Cancer Center organized in sessions of 60 to 75 minutes in duration, with a frequency of 2 days/week for 12 weeks; In addition, 3 sessions of nutritional counseling and 3 sessions of psycho-oncological intervention will be developed.
- interventionNames
- Behavioral: Physical exercise
- Behavioral: Nutritional advice
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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).
References
Publications (4)
- RESULTFrancis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4. PMID 29863451
- RESULTFrancis PA, Fleming GF, Lang I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman RE, Muller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 1;41(7):1370-1375. doi: 10.1200/JCO.22.01065. Epub 2022 Dec 9. PMID 36493334
- RESULTLu YS, Wong A, Kim HJ. Ovarian Function Suppression With Luteinizing Hormone-Releasing Hormone Agonists for the Treatment of Hormone Receptor-Positive Early Breast Cancer in Premenopausal Women. Front Oncol. 2021 Sep 14;11:700722. doi: 10.3389/fonc.2021.700722. eCollection 2021. PMID 34595110
- DERIVEDHerrero Lopez B, Castellanos Montealegre M, Soulas C, Rufrancos BA, Garcia-Ontiveros Cuellar ML, Del Monte Millan M, Villarejo Lopez L, Lopez-Tarruella Cobo S, Jerez Gilarranz Y, Echavarria Diaz-Guardamino I, Jara P, Jimenez MM, Sanchez TM, Martinez Beltran MJ, de la Torre Montero JC, Casla Barrio S. 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. Front Oncol. 2025 Oct 27;15:1622622. doi: 10.3389/fonc.2025.1622622. eCollection 2025. PMID 41220947