[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578036":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":33,"responsibleParty":65,"collaborators":67,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":18,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Parc de Salut Mar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Balneotherapy group","EXPERIMENTAL","These participants will be premenopausal women with estrogen receptor positive early breast cancer treated with adjuvant endocrine therapy allocated to receive 4 weeks of 3 weekly sessions of balneotherapy.",[13],"Other: Balneotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","These participants will be premenopausal women with estrogen receptor positive early breast cancer treated with adjuvant endocrine therapy that will not receive balneotherapy but that will be asked to respond to the same scales and questionnaires as the balneotherapy group at the same timepoints.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Balneotherapy","The intervention consists in 3 weekly sessions of balneotherapy during 4 weeks.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Natalia Garcia-Giralt, PhD","CONTACT","0034933160497","ngarcia@researchmar.net",{"name":31,"role":27,"phone":18,"phoneExt":18,"email":32},"Diana Ovejero, MD, PhD","dovejero@researchmar.net",[34],{"facility":35,"status":18,"city":36,"state":18,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Parc de Recerca Biomèdica de Barcelona","Barcelona","08003","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],2.15899,41.38879,{"lat":44,"lon":43},[47,49,50,53,55,57,59,61,63],{"name":26,"role":27,"phone":48,"phoneExt":18,"email":29},"0034-933161497",{"name":31,"role":27,"phone":48,"phoneExt":18,"email":32},{"name":51,"role":52,"phone":18,"phoneExt":18,"email":18},"Natalia Garcia Giralt, PhD","PRINCIPAL_INVESTIGATOR",{"name":31,"role":54,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":56,"role":54,"phone":18,"phoneExt":18,"email":18},"Xavier Nogues, MD, PhD",{"name":58,"role":54,"phone":18,"phoneExt":18,"email":18},"Anna Ribes, MSc",{"name":60,"role":54,"phone":18,"phoneExt":18,"email":18},"Sònia Servitja, MD, PhD",{"name":62,"role":54,"phone":18,"phoneExt":18,"email":18},"Joan Albanell, MD, PhD",{"name":64,"role":54,"phone":18,"phoneExt":18,"email":18},"Tamara Martos, MD",{"type":66,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[68,71,73],{"name":69,"class":70},"Caldes de Montbui's City Council","UNKNOWN",{"name":72,"class":6},"European Regional Development Fund",{"name":74,"class":70},"Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)","100578036","balneotherapy-for-breast-cancer-patients-undergoing-endocrine-therapy-100578036",false,"NCT06806072","BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY","EFFECTS OF BALNEOTHERAPY IN BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY","Inclusion Criteria:\n\nPremenopausal women diagnosed with early-stage hormonal receptor (HR+) breast cancer (stages I-III) undergoing ovarian suppression and aromatase inhibitor therapy (i.e., endocrine therapy) for at least three months.\n\n\\- Reported musculoskeletal pain (VAS score ≥2) associated with the initiation of the endocrine therapy.\n\nExclusion Criteria\n\n* Chronic musculoskeletal conditions predating the initiation of endocrine therapy and\u002For unrelated to effects derived from the endocrine therapy (i.e. fibromyalgia)\n* Anxiety-depression syndrome predating the initiation of endocrine therapy that is treated with drugs.\n* Fear of water\n* Fecal and\u002For urinary incontinence\n* Severe venous insufficiency\n* Epilepsy and physical disabilities that may hinder the performance of Balneotherapy (BT)\u002Faquatic exercises.","FEMALE","18 Years","55 Years",{"count":86,"type":87},96,"ESTIMATED","INTERVENTIONAL",[90],"NA","Endocrine therapy is the mainstay of adjuvant therapy in premenopausal women with hormone receptive-positive (HR+) breast cancer as it has been demonstrated that it reduces long-term recurrences and increases survivial. However, this therapy, which suppresses estrogen production and estrogen-induced effects, is associated with the development of joint pain which can significantly reduce quality of life and lead to treatment discontinuation.\n\nThe main question the study aims o answer is:\n\nCan balneotherapy (BT) alleviate muscle-skeletal pain (primary objective) derived from endocrine therapy and improve quality of life (secondary objective) in young women with HR+ breast cancer?",[93],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[95,96,97],"breast cancer","balneotherapy","endocrine therapy","NOT_YET_RECRUITING","2025-01-30",{"date":101,"type":102},"2025-02-03","ACTUAL",{"date":104,"type":87},"2025-02-10",{"date":106,"type":87},"2027-05-31",{"name":5,"class":6},1]