[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616859":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":29,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":32,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Kliniken Essen-Mitte","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot","ACTIVE_COMPARATOR","Switching to a high-fibre diet is supported by multi-professional consultation hours, individual counselling and group sessions that combine mind-body medicine and nutritional therapy content.",[13],"Other: switching to a high-fibre diet",{"label":15,"type":10,"description":16,"interventionNames":17},"control group receives official dietary recommendations","Control group receives standard care, i.e. a leaflet and an educational training video with dietary recommendations of the Deutsche Gesellschaft fuer Ernaehrung (DGE)",[18],"Other: official dietary recommendations",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"switching to a high-fibre diet","The aim of the intervention is to support patients in implementing a high-fibre diet (20-30 g of fibre per day) before and during systemic therapy. A multi-professional team consisting of a specialist doctor, a qualified nutritionist and an MBM therapist ensures comprehensive support during lifestyle modification. While the nutritional counselling provides recommendations for optimising diet, the MBM intervention addresses behavioural factors such as motivation, self-efficacy expectations and dealing with barriers to action. In addition, the specialist provides advice on symptom management.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"official dietary recommendations","providing official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE)",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Evang. Kliniken Essen-Mitte gGmbH","RECRUITING","Essen","North Rhine-Westphalia","45276","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],7.01228,51.45657,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Petra Voiss, PD Dr.","CONTACT","004920117439001","p.voiss@kem-med.com",{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[53],{"name":54,"class":6},"Karl and Veronica Carstens Foundation","100616859","feasibility-of-a-lifestyle-intervention-for-women-with-triple-negative-breast-cancer-under-neoadjuvant-immunotherapy-100616859",false,"NCT07311083","Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy","Feasibility of a Lifestyle Intervention to Switch to a High-fiber, Gut-healthy Diet in Women With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy: a Randomized Controlled Trial","BallastImmun","Inclusion Criteria:\n\n* Female patients aged 18-75\n* Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy\n* Willingness to participate in the study and signed consent form\n\nExclusion Criteria:\n\n* Advanced stage of disease with metastases\n* Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study\n* Pregnancy\n* Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions\n* A diet that is incompatible with a high-fiber diet, such as the ketogenic diet\n* Abuse of drugs and\u002For alcohol\n* Inability to complete the questionnaires independently\n* Colectomy\n* Gastrointestinal stenosis\n* Fructose intolerance\n* Histamine intolerance\n* Gluten intolerance\n* Ketogenic diet\n* Unwillingness to refrain from taking probiotics for the duration of the study\n* Eating disorders\n* No laptop and\u002For camera available to participate in the online group training program","FEMALE","18 Years","75 Years",{"count":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"NA","Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients.\n\nStudies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved.\n\nThe aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.",[74],"Microbiome","2026-05-05",{"date":77,"type":78},"2026-05-08","ACTUAL",{"date":80,"type":78},"2026-02-01",{"date":82,"type":68},"2027-07-01",{"name":5,"class":6},1]