[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571994":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":53,"locations":62,"responsibleParty":90,"collaborators":92,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":28,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":64,"whyStopped":28,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Universidad Pontificia Comillas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1, control","ACTIVE_COMPARATOR","Group 1\u002FControl: 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:\u002F\u002Fapps.who.int\u002Firis\u002Fbitstream\u002Fhandle\u002F10665\u002F337004\u002F9789240014817-spa.pdf).",[13],"Behavioral: Basic recommendations",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2, experimental","EXPERIMENTAL","Group 2\u002F 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\u002Fweek for 12 weeks; In addition, 3 sessions of nutritional counseling and 3 sessions of psycho-oncological intervention will be developed.",[19,20,21],"Behavioral: Physical exercise","Behavioral: Nutritional advice","Behavioral: Psycho-oncological support",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Basic recommendations","Daily basis activity counseling by WHO recommendations",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Physical exercise","A complete program of active physical exercise of medium and high intensity",[15],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Nutritional advice","A complete program of nutritional counseling",[15],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Psycho-oncological support","A program related with a patient Psycho-oncological follow-up",[15],[42,45,49],{"name":43,"affiliation":5,"role":44},"Julio C de la Torre, Ph.D","STUDY_CHAIR",{"name":46,"affiliation":47,"role":48},"Blanca Herrero López, MD","Hospital Universitario Gregorio Marañón","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":52},"Soraya Casla Barrio, Ph.D","Comillas Pontifical University","STUDY_DIRECTOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":28,"email":58},"Julio C de la Torre-Montero, Ph.D","CONTACT","+34678581021","juliodelatorre@comillas.edu",{"name":60,"role":56,"phone":28,"phoneExt":28,"email":61},"Maria Jesús Martínez Beltrán, Ph.D","mjesus.martinez@comillas.edu",[63,81],{"facility":5,"status":64,"city":65,"state":28,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Madrid","28015","Spain","ES",{"type":70,"coordinates":71},"Point",[72,73],-3.70256,40.4165,{"lat":73,"lon":72},[76,79],{"name":77,"role":56,"phone":78,"phoneExt":28,"email":58},"Julio C. de la Torre-Montero, Ph.D","+34 678581021",{"name":80,"role":56,"phone":28,"phoneExt":28,"email":28},"S., Ph.D",{"facility":82,"status":64,"city":65,"state":28,"zip":28,"country":67,"countryCode":68,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Hospital General Universitario Gregorio Marañón",{"type":70,"coordinates":84},[72,73],{"lat":73,"lon":72},[87],{"name":88,"role":56,"phone":28,"phoneExt":28,"email":89},"Blanca Herrero-López, MD","b.herrero88@gmail.com",{"type":91,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[93,95],{"name":94,"class":6},"Hospital General Universitario Gregorio Marañon",{"name":96,"class":97},"San Juan de Dios Foundation","UNKNOWN","100571994","ovs-breast-ovarian-suppression-in-breast-cancer-interventions-100571994",false,"NCT06727487","OvS Breast: Ovarian Suppression in Breast Cancer Interventions","OvS Breast: ENBI Project, Ovarian Suppression in Breast Cancer: Exercise, Nutrition and Behavioural Intervention Project","ENBI","Inclusion Criteria:\n\n* Women who have reached the age of majority and up to 45 years of age.\n* Premenopausal status is defined clinically as a patient who maintains menstruation prior to the start of chemotherapy treatment if this has taken place.\n* Confirmed histological diagnosis of infiltrating breast carcinoma with expression of ER and\u002For RP stage I to III.\n* Loco-regional treatment with surgery and radiotherapy, if any, completed.\n* 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.\n* Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-1.\n* Ability to understand and agree to the Informed Consent in writing.\n\nExclusion Criteria:\n\n* Presence of medical contraindications to perform physical exercise.\n* Presence of any of the American Thoracic Society (ATS) criteria to perform a cardiovascular capacity test.\n* Presence of active neoplastic disease: metastatic breast cancer or other active tumor diseases.\n* Pregnancy or breastfeeding.\n* Alcohol or other drug abuse (excluding smoking).","FEMALE","18 Years","45 Years",{"count":110,"type":111},30,"ESTIMATED","INTERVENTIONAL",[114],"NA","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\u002For PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment.\n\nThe 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.\n\nThe 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.",[117],"Breast Neoplasms",[119,34,120,121],"Physical Exercise","Psico-oncological support","Patient Report Outcomes","2024-12-06",{"date":124,"type":125},"2024-12-11","ACTUAL",{"date":127,"type":125},"2024-11-15",{"date":129,"type":111},"2025-12-15",{"name":5,"class":6},2]