[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601215":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","107 women that will follow the standard of care. Patients in the control group will receive proper information and recommendations about lifestyle modifications according to the most recent oncological guidelines. The benefits of physical exercise, a healthy diet and psychological support will be exposed, but such interventions will not be provided in our centre.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Prehabilitation","EXPERIMENTAL","107 women that will follow the multimodal prehabilitation program during NACT (physical exercise, psychological intervention, nutritional support).",[18],"Behavioral: Multimodal prehabilitation",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Multimodal prehabilitation","Multimodal prehabilitation program during NACT (4-6 months) that will combine: 1) Physical exercise: cardiovascular and strength exercises designed by specialized physiotherapists, structured in 1-hour sessions twice a week. The characteristics of the activity will be adapted to the treatment phase and the physical condition of each woman. 2) Psychological therapies: standardized mindfullness practice by a specialized psychologist. As an alternative, patients who refuse mindfullness could receive psychological sessions on stress and anxiety management. 3) Nutritional counseling: periodic sessions with a specialized nutritionist providing dietary recommendations and nutritional advice adapted to the disease and condition of the patients.",[14],[26,29],{"name":27,"affiliation":5,"role":28},"Berta Díaz-Feijoo, MD, PhD","STUDY_DIRECTOR",{"name":30,"affiliation":5,"role":28},"Eduard Mension Coll, MD, PhD",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Helena Castillo Espín, MD","CONTACT","+34 651024667","hcastillo@clinic.cat",{"name":30,"role":34,"phone":38,"phoneExt":12,"email":39},"+34 626 20 71 71","mension@clinic.cat",[41],{"facility":42,"status":43,"city":44,"state":12,"zip":12,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Clínic de Barcelona","RECRUITING","Barcelona","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],2.15899,41.38879,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":56,"phoneExt":57,"email":36},"Helena Castillo, M.D., PhD student","+34 932275534","5534",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Helena Castillo","Medical Doctor (MD), Specialized in Gynecology and Obstetrics",[63],{"name":64,"class":6},"Fundació La Marató de TV3","100601215","multimodal-prehabilitation-program-that-combines-physical-exercise-psychological-intervention-and-nutritional-support-to-improve-the-response-to-neoadjuvant-chemoterhapy-in-early-breast-cancer-patients-100601215",false,"NCT07107594","Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients","Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)","DIANA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).\n* Age ≥ 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Contraindication or physical inability to perform moderate-to-high intensity physical exercise.\n* Pregnant or breastfeeding patients.\n* Presence of other active synchronous neoplasms.\n* Metastatic breast cancer (stage IV).\n* Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week.\n* Male breast cancer patients.\n* Personal history of a previous malignancy treated with chemotherapy.\n* Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).","FEMALE","18 Years",{"count":76,"type":77},214,"ESTIMATED","INTERVENTIONAL",[80],"NA","The aim of this clinical trial is to evaluate whether following a multimodal prehabilitation program including physical exercise, nutritional support and psychological intervention during neoadjuvant chemotherapy in breast cancer patients could improve the pathological response to chemotherapy.\n\n214 women with non-metastatic breast cancer with indication of chemotherapy before surgery will be eligible to participate. Patients will be randomly assigned to either the intervention group or the control group.\n\n* Patients assigned to the intervention group (107 women) will undergo a directed multimodal prehabilitation program during the chemotherapy (4-6 months), including structured physical exercise, psychological intervention and nutritional guidance.\n* Patients assigned to the control group (107 women) will undergo standard clinical management for their disease without multimodal prehabilitation.\n\nThe response to chemotherapy between the two groups will be evaluated and compared. It is expected that multimodal prehabilitation will increase the response to chemotherapy and will improve the postoperative recovery of patients and their quality of life, as well as reducing the number of complications from surgery and chemotherapy treatment. Changes in the tumor microenvironment are also expected after prehabilitation.",[83,14],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[85,86,14,22,87,88,89],"Breast cancer","Early breast cancer","Neoadjuvant chemotherapy","Lifestyle","Quality of life","2026-01-14",{"date":92,"type":93},"2026-01-15","ACTUAL",{"date":95,"type":93},"2025-01-14",{"date":97,"type":77},"2028-03",{"name":5,"class":6},1]