OvS Breast: Ovarian Suppression in Breast Cancer Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Basic recommendations, Physical exercise, Nutritional advice, Psycho-oncological support.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
Overview
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.
Detailed description
Breast cancer (BC) is the most common and incident neoplasia in women in Spain and is the third cause of cancer death after lung and colorectal cancer. In turn, BC with hormone receptor expression is the most common and corresponds to approximately 75% of BC cases.
Suppression of ovarian function combined with endocrine treatment (gonadotropin-releasing hormone analog (LHRH) associated with tamoxifen (TAM) or aromatase inhibitors (AI)) has demonstrated a benefit in terms of relapse-free survival (PFS) and overall survival (OS) in premenopausal women diagnosed with localized BC with estrogen receptor (ER) and progesterone (PR) expression. This benefit is mainly focused on patients diagnosed at younger ages (under 45 years) and those with other clinical-pathological factors that imply an exceptionally high risk of relapse.
Despite their benefits, the adverse effects of these treatments are not trivial and include significant toxicities in the cardiorespiratory, metabolic, sexual, and emotional spheres. Metabolic alterations include unfavorable changes in body composition with increases in the percentage of fat and weight that can be observed already in the first months of treatment, which in turn is directly related to an increased risk of BC relapse in these patients.
Changes in body composition with increased fat and decreased muscle mass lead to a pro-inflammatory and dysfunctional state of the immune system, which in turn has been linked to the development of cardiovascular diseases and a worse oncological prognosis.
Scientific evidence suggests that nutritional interventions combined with physical exercise and adapted to physiological needs, the baseline physical level, and the adverse effects derived from the treatments can be safe and effective in achieving adequate weight control and body composition. All of this would favor restoring the immune system's functionality and increasing patients' cardiorespiratory capacity (CRF), which could ultimately translate into a better quality of life.
However, adherence to these programs is low for many reasons, and psycho-oncological support with behavioral interventions could favor adherence to them and stimulate changes in patients' lifestyles.
Despite the evidence, there is no scientific consensus regarding the dosage of exercise and the type of nutritional intervention that should be applied to patients with BC whose treatment includes suppression of ovarian function. In this sense, these interventions should be individualized and adapted to the characteristics of each patient, taking into account all the factors that could affect adherence to these programs.
This project has been designed as a pilot study to evaluate the impact of an intervention program incorporating physical exercise and nutritional control strategies adapted to the baseline situation and level of physical fitness of each premenopausal patient with localized BC on adjuvant treatment with ovarian function suppression.
HYPOTHESIS AND OBJECTIVES: 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 PR expression who receive aLHRH in combination with TAM or AI as part of their 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 of body fat and increase of 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, patient-reported outcomes (PROs) (exercise level, asthenia, self-perception, anxiety, and depression), blood count and biochemistry values that could be modified, nutritional status and side effects of the treatments.
The exploratory objectives, on the other hand, consist of evaluating the impact of the combined intervention on the levels of pro-inflammatory substances (C-reactive protein (CRP) and TNF-alpha) and anti-inflammatory substances (adiponectin) as well as on the levels of oncostatin M, a myokine whose release increases with exercise and seems to stimulate apoptosis and interfere with exercise.
Interventions
- Behavioral Basic recommendations
Daily basis activity counseling by WHO recommendations - Behavioral Physical exercise
A complete program of active physical exercise of medium and high intensity - Behavioral Nutritional advice
A complete program of nutritional counseling - Behavioral Psycho-oncological support
A program related with a patient Psycho-oncological follow-up
Primary outcome measures
- Combined intervention evaluation on weight control [Time frame: 1 year]
- Combined intervention evaluation in body composition [Time frame: 1 year]
Secondary outcome measures (7)
- Improve Quality of Life on Patient Report Outcomes [Time frame: 1 year]
- Nutritional Status follow-up [Time frame: 1 year]
- Psycho-oncological assessment [Time frame: 1 year]
- Cardiorespiratory Fitness: Evaluation of physical activity performance [Time frame: 1 year]
- Endurance performance: Evaluation of physical activity performance: [Time frame: 1 year]
- Strength: Evaluation of physical activity performance [Time frame: 1 year]
- Physical functionality: Evaluation of physical activity performance [Time frame: 1 year]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Universidad Pontificia Comillas — Madrid
- Hospital General Universitario Gregorio Marañón — Madrid
Publications
- 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 PMID 29863451
- Francis 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 PMID 36493334
- Lu 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
- Herrero 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 intervent PMID 41220947
Identifiers
NCT: NCT06727487 · ENBI_2023