[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554302":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":18,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":99,"whyStopped":18,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University Hospital of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","All women in the experimental group receive standardized high-intensity interval training over a period of 6 months in combination with neoadjuvant therapy (immunochemotherapy). The individual training sessions are guided and monitored by qualified exercise therapists, taking into account the side effects of ongoing treatment. Each training session will last about one hour, with the effective training time being 30 minutes. Bike training begins 1 hour before neoadjuvant therapy and then at the same time of day between therapies. The TNBC patients start with 5 minutes of cycling followed by 3 × 3 - minute HIIT training sequences, constantly alternating: i) 30 s at 90% of maximal PO (70 rpm for 30 s) and ii) 30 s of light pedaling at 20% of PO). The training session will be concluded with a 5-min cool-down cycling (easy pedaling) and stretching. This protocol will be performed twice a week throughout the study.",[13],"Other: Exercise intervention - High intensity interval training on a cycle-ergometer",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group will receive the standard care during their neoadjuvant therapy (immunochemotherapy) over a 6-month period.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Exercise intervention - High intensity interval training on a cycle-ergometer","The experimental group starts with 5 minutes of unloaded cycling, followed by 3 × 3-minute HIIT training sequences alternating between: i) 30 seconds at 90% of maximal PO (70 rpm for 30 seconds) and ii) 30 seconds of light pedaling at 20% of PO). Recent work suggests that this high-intensity approach to aerobic exercise is feasible and safe, even during acute oncology treatment. The HIIT sequences are interspersed with two 3-minute cycling sessions at moderate intensity. The training session will be concluded with a 5-minute cool-down by cycling (light pedaling) and stretching. This protocol will be performed twice a week throughout the study, and all patients who reach an 80% adherence threshold for the exercise intervention will be included in the final analysis.",[9],[25],{"name":26,"affiliation":5,"role":27},"Freerk T Baumann, PhD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","0221-478-42649","freerk.baumann@uk-koeln.de",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},"Damir Zubac, PhD","damir.zubac@uk-koeln.de",[37],{"facility":38,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Hospital of Cologne and St. Elizabeth Hospital","Cologne","North Rhine-Westphalia","50937","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],6.95,50.93333,{"lat":48,"lon":47},[51,53,55,56,58,60,62,64],{"name":34,"role":30,"phone":52,"phoneExt":18,"email":35},"0221 478-97185",{"name":54,"role":30,"phone":18,"phoneExt":18,"email":32},"Freerk T baumann, PhD",{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":34,"role":57,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":59,"role":57,"phone":18,"phoneExt":18,"email":18},"Paul Bröckelmann, MD, PhD",{"name":61,"role":57,"phone":18,"phoneExt":18,"email":18},"Michael Mendes Wefelnberg",{"name":63,"role":57,"phone":18,"phoneExt":18,"email":18},"Julian Puppe, MD",{"name":65,"role":27,"phone":18,"phoneExt":18,"email":18},"Susanne Brandner, MD",{"type":27,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Freerk Bauman","Prof.dr. Freerk T. Baumann",[70],{"name":71,"class":72},"St. Elisabeth Krankenhaus Köln-Hohenlind","UNKNOWN","100554302","exercise-intervention-in-women-diagnosed-with-triple-negative-breast-cancer-receiving-oncologic-treatment-100554302",false,"NCT06497322","Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment","Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging\n* Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2\n* Deemed eligible for intended treatment with Paclitaxel 80mg\u002Fm2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg\u002F m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician\n* Treatment in curative intent with life expectancy ≥ 3 months\n* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.\n* Sufficient German language skills;\n\nExclusion Criteria:\n\n* History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Any history of previous systemic treatment for TNBC;\n* Any diseases that do not allow sports activity, such as:\n\n  * Clinically-manifest heart failure (NYHA III-IV);\n  * Respiratory partial or global insufficiency;\n  * Permanent thrombocytopenia \\\u003C10,000\u002Fµl, e.g., refractory autoimmune thrombocytopenia;\n  * Congenital or acquired thrombocytopathies or coagulation disorders.\n  * Symptomatic CHD (clearance certificate required, stress ECG and cardiac ultrasound recommended if necessary);\n* Participation in another exercise study;","FEMALE","18 Years","85 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"NA","In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.",[91,92],"Breast Cancer","Triple Negative Breast Cancer",[94,95,96,97,98],"Exercise","Immunotherapy","Oxygen uptake","CT scan","Blood markers","NOT_YET_RECRUITING","2024-07-04",{"date":102,"type":103},"2024-07-11","ACTUAL",{"date":105,"type":85},"2024-09-01",{"date":107,"type":85},"2027-12-31",{"name":5,"class":6},1]