OvS Breast: Ovarian Suppression in Breast Cancer Interventions
ENBI
OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedStudy Start
First participant enrolled
November 15, 2024
CompletedFirst Posted
Study publicly available on registry
December 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedDecember 11, 2024
December 1, 2024
5 months
October 10, 2023
December 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Combined intervention evaluation on weight control
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 breast cancer expressing estrogen receptors and progesterone receptors who receive adjuvant treatment. The psycho-oncological intervention program aims to increase motivation to adhere to the physical exercise program and nutritional recommendations and maintain long-term healthy lifestyle habits.
1 year
Combined intervention evaluation in body composition
The variables weight, kilograms, fat mass, lean mass, and extracellular water will be obtained with the Tanita BC-601 Gold scale, including an impedance meter. The height, waist, and hip circumferences will be obtained with a tape measure. These measurements are necessary for calculating the BMI and the waist-high index (measure in centimeters). Weight and height will be combined to report BMI in kg/m\^2 Units of measure: weight in kilograms, height in meters.
1 year
Secondary Outcomes (7)
Improve Quality of Life on Patient Report Outcomes
1 year
Nutritional Status follow-up
1 year
Psycho-oncological assessment
1 year
Cardiorespiratory Fitness: Evaluation of physical activity performance
1 year
Endurance performance: Evaluation of physical activity performance:
1 year
- +2 more secondary outcomes
Study Arms (2)
Group 1, control
ACTIVE COMPARATORGroup 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).
Group 2, experimental
EXPERIMENTALGroup 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.
Interventions
Daily basis activity counseling by WHO recommendations
A complete program of active physical exercise of medium and high intensity
A program related with a patient Psycho-oncological follow-up
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Pontificia Comillaslead
- Hospital General Universitario Gregorio Marañoncollaborator
- San Juan de Dios Foundationcollaborator
Study Sites (2)
Universidad Pontificia Comillas
Madrid, 28015, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Related Publications (4)
Francis 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: 29863451RESULTFrancis 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: 36493334RESULTLu 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: 34595110RESULTHerrero 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: 41220947DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Julio C de la Torre, Ph.D
Universidad Pontificia Comillas
- PRINCIPAL INVESTIGATOR
Blanca Herrero López, MD
Hospital Universitario Gregorio Marañón
- STUDY DIRECTOR
Soraya Casla Barrio, Ph.D
Comillas Pontifical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2023
First Posted
December 11, 2024
Study Start
November 15, 2024
Primary Completion
April 15, 2025
Study Completion
December 15, 2025
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 2 years
- Access Criteria
- Public access
A complete publication plan will be taken into account, covering everything from the protocol to the dissemination of the results in scientific journals and scientific forums, such as specialized conferences.