Breast NeoplasmsENBINCT06727487
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
A study testing Basic recommendations, Physical exercise and Nutritional advice in people with Breast Neoplasms, run by Universidad Pontificia Comillas at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Basic recommendations, Physical exercise and Nutritional advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Nov 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Jesús Martínez Beltrán, Ph.D contact
Spain2 sites, 2 recruiting
- Recruiting
Universidad Pontificia Comillas
Madrid, 28015
Julio C. de la Torre-Montero, Ph.D, +34 678581021, juliodelatorre@comillas.edu
S., Ph.D
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Blanca Herrero-López, MD, b.herrero88@gmail.com
About this study
Official title: OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Basic recommendations, Physical exercise, Nutritional advice, Psycho-oncological support
- Keywords
- Physical Exercise, Nutritional advice, Psico-oncological support, Patient Report Outcomes
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic recommendationsBehavioural
Daily basis activity counseling by WHO recommendations
Physical exerciseBehavioural
A complete program of active physical exercise of medium and high intensity
Nutritional adviceBehavioural
A complete program of nutritional counseling
Psycho-oncological supportBehavioural
A program related with a patient Psycho-oncological follow-up
| Study group | Role | What they receive |
|---|---|---|
| Group 1, control | Active comparator | 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). Receives: Behavioral: Basic recommendations |
| Group 2, experimental | Experimental | 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. Receives: Behavioral: Physical exercise; Behavioral: Nutritional advice; Behavioral: Psycho-oncological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (7)
Improve Quality of Life on Patient Report Outcomes
To evaluate the impact of the combined intervention program on patient-reported outcomes (PROs) (exercise level , asthenia, self-perception, anxiety and depression).
The combination of several validated tests allows us to establish a balanced measure with the multi-professional approaches that care for the patient.
Patient Reported Outcomes (PROs): These will be assessed and collected by completing validated questionnaires for this purpose.
- Quality of life: EuroQoL-5D questionnaire
- Fatigue: FACIT-Fatigue questionnaire
- Level of physical activity: International Physical Activity Questionnaire (IPAQ)
- Self-perception/self-esteem: Rosemberg Self-Esteem Scale
- Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS)
Measured: 1 year
Nutritional Status follow-up
Nutritional status: It will be assessed using the following tools at the beginning, 6 weeks after the start of the intervention and at the end of the 12 weeks.The combination of several validated tests allows us to establish a balanced measure of the specific situation in each patient.
- 3-day nutritional record
- Predimed Mediterranean diet adherence questionnaire
- WCRF/AICR recommendations compliance scale
Measured: 1 year
Psycho-oncological assessment
Psycho-oncological assessment: It will be assessed with the following questionnaires that the patient will complete at the beginning and the end of the 12 weeks of intervention.
The combination of several validated tests allows us to establish a measure that relates the emotional state with the variables of physical exercise The PANAS affectivity scale will have an additional intermediate evaluation six weeks after the start of the intervention.
- PANAS affectivity scale
- Transtheoretical model of change in physical exercise (CMTCEJ) questionnaire.
- MOS social support questionnaire
Measured: 1 year
Cardiorespiratory Fitness: Evaluation of physical activity performance
Evaluation of physical activity performance thought:
-Cardiorespiratory fitness (CRF): The Bruce test will be evaluated to determine the maximum oxygen consumption (VO2max, milliliters/kilogram/minute). -Cardiac variability (HR at rest and maximum (beats/minute)): It will be measured with an HR receiver before the Bruce test (at rest) and at the time of finishing it (maximum effort)
Measured: 1 year
Endurance performance: Evaluation of physical activity performance:
-Endurance performance (capillary lactate levels (millimoles/liter): They will be evaluated with a lactate analyzer at rest, at the time of finishing it (maximum effort), and two minutes after having finished it.
Measured: 1 year
Strength: Evaluation of physical activity performance
-Strength: It will be evaluated using dynamometry of the upper and lower body, as well as with the squat test and shoulder press with load (kilograms mobilized and repetitions performed).
Measured: 1 year
Physical functionality: Evaluation of physical activity performance
-Physical functionality: It will be measured with the maximum squat test in 30 seconds (number of repetitions) and 6-minute walk (maximum distance in meters that the patient can walk for 6 minutes).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Nov 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon, San Juan de Dios Foundation
- Responsible party
- Sponsor
- Investigators
- Julio C de la Torre, Ph.D, Study chair, Universidad Pontificia ComillasBlanca Herrero López, MD, Principal investigator, Hospital Universitario Gregorio MarañónSoraya Casla Barrio, Ph.D, Study director, Comillas Pontifical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727487
- Sponsor's protocol ID
- ENBI_2023
- Acronym
- ENBI
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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, 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.
PubMed 29863451Francis 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.
PubMed 36493334Lu 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.
PubMed 34595110Herrero 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.
PubMed 41220947
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project
- ClinicalTrials.gov ID
- NCT06727487
- Acronym / sponsor ID
- ENBI / ENBI_2023
- Conditions
- Breast Neoplasms
- Keywords
- Physical Exercise, Nutritional advice, Psico-oncological support, Patient Report Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon, San Juan de Dios Foundation
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, control | Active comparator | Behavioral: Basic recommendationsGroup 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 | Experimental | Behavioral: Physical exercise, Behavioral: Nutritional advice, Behavioral: Psycho-oncological supportGroup 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic recommendationsDaily basis activity counseling by WHO recommendations | Behavioural | Group 1, control |
| Physical exerciseA complete program of active physical exercise of medium and high intensity | Behavioural | Group 2, experimental |
| Nutritional adviceA complete program of nutritional counseling | Behavioural | Group 2, experimental |
| Psycho-oncological supportA program related with a patient Psycho-oncological follow-up | Behavioural | Group 2, experimental |
Primary outcome
Combined intervention evaluation on weight control
Time frame: 1 year
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.
Combined intervention evaluation in body composition
Time frame: 1 year
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Results publication: PubMed 29863451Francis 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.
- Results publication: PubMed 36493334Francis 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.
- Results publication: PubMed 34595110Lu 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.
- Derived from this study: PubMed 41220947Herrero 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.
- Cancer epidemiology in SpainLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Jesús Martínez Beltrán, Ph.D contact
Julio C de la Torre, Ph.D study chair
Universidad Pontificia Comillas
Blanca Herrero López, MD principal investigator
Hospital Universitario Gregorio Marañón
Soraya Casla Barrio, Ph.D study director
Comillas Pontifical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic recommendations, Physical exercise and Nutritional advice in people with Breast Neoplasms, run by Universidad Pontificia Comillas at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julio C de la Torre-Montero, Ph.D (+34678581021, juliodelatorre@comillas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined intervention evaluation on weight control (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727487, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.