[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644605":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":51,"centralContacts":55,"locations":65,"responsibleParty":81,"collaborators":26,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":26,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Masaryk Memorial Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL","Participants undergo a multimodal prehabilitation and perioperative optimization program. Intervention includes supervised home-based exercise training prescribed according to the ACSM FITT principles for 8 weeks, incorporating inspiratory muscle training initiated at 60% of baseline maximal inspiratory pressure and progressively adjusted based on perceived exertion, together with aerobic exercise at 60-80% heart rate reserve. Training is delivered via telemedicine with regular remote supervision. Cardiorespiratory fitness is assessed at baseline, after completion of neoadjuvant therapy, and 6 months postoperatively. Participants will receive comprehensive nutritional assessment and individualized nutritional support, structured psychological counseling at predefined study time points, and perioperative care according to ERAS principles. Quality of life is evaluated using validated questionnaires. Cellular and humoral immunity and endocrine function are monitored longitudinally using",[13,14,15,16,17,18,19],"Diagnostic Test: Cardiorespiratory fitness (FsPS)","Other: Exercises you can do on your own at home","Other: Enhanced Recovery After Surgery ERAS","Other: Nutritional support","Other: Psychological support","Other: Quality of life","Diagnostic Test: Laboratory tests",[21,27,31,35,39,43,47],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Cardiorespiratory fitness (FsPS)","A single measurement before the start of preoperative treatment (baseline), after completion of chemotherapy 4-2 weeks before surgery, and 6 months after surgery.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Exercises you can do on your own at home","Exercise training is prescribed in accordance with the guidelines for prescribing physical activity (the FITT methodology published by the ACSM in 2018) for a period of 2 months. Training is set at 60% of the baseline maximum inspiratory pressure (MIP) and is increased by 5% if the participant reports a rate of perceived exertion (RPE) \\\u003C 7 (RPE scale 1-10). Exercises is conducted under supervision using telemedicine technologies. Weekly online check-ins via video call using the MOU MEDDI platform (first 4 weeks), then once every 14 days. Alternatively, weekly training sessions at the gym for the first 4 weeks (3 times a week at home, walking for at least 30 minutes per training session), followed by independent training at home. The intensity of aerobic training is prescribed based on a target heart rate of 60-80% of the heart rate reserve. An important part of the evaluation is also the patient's adherence to the exercise intervention and their level of physical activity.",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Enhanced Recovery After Surgery ERAS","1. Preoperative evaluation in the Anesthesiology and Resuscitation Department (ARD)\u002FIntensive Care Unit (ICU) and preoperative intensive care, assessment of the patient's condition, development of an anesthetic plan, and consultation with the patient and their family members.\n2. Application of ERAS principles in the immediate preoperative period.\n3. Application of ERAS principles intraoperatively.\n4. Application of ERAS principles for the postoperative period.\n5. Implementation of early detection of complications and their immediate resolution.",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Nutritional support","1. Assessment of nutrition using the SGA (Seven-Point Subjective Global Assessment)\n2. Assessment of nutritional status (nutritional requirements) using laboratory values, anthropometry, and bioimpedance\n3. Assessment of weight loss or gain using selected parameters\n4. Assessment of intake of regular food, oral dietary supplements, dietary modifications, and artificial nutrition",[9],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":26},"Psychological support","Psychological intervention is provided to each patient at the following time points: 1) upon enrollment in the study, 2) before surgery, 3) 30 days after surgery, and 4) 6 months after surgery.",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"Quality of life","It is assessed using standardized questionnaires.",[9],{"type":22,"name":48,"description":49,"armGroupLabels":50,"otherNames":26},"Laboratory tests","Monitoring of cellular and humoral immunity\u002Fendocrine function will be performed by flow cytometry using two peripheral blood samples (1 tube containing 2.7 mL of EDTA-anticoagulated blood and 1 tube containing 5 mL of anticoagulant-free blood for serum separation) at 4 time points: 1) upon study enrollment, 2) before surgery, 3) 30 days after surgery, and 4) 6 months after surgery. Multicolor (6 to 8 colors) protocols for the proposed immune profile have already been established.",[9],[52],{"name":53,"affiliation":5,"role":54},"Radka Lordick Obermannová, Doc, MD, PhD","PRINCIPAL_INVESTIGATOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},"Martina Lojová, PhD","CONTACT","+420543136232","martina.lojova@mou.cz",{"name":62,"role":58,"phone":63,"phoneExt":26,"email":64},"Tereza Štěpánková, PhD","+420543136223","tereza.stepankova@mou.cz",[66],{"facility":5,"status":67,"city":68,"state":26,"zip":69,"country":70,"countryCode":26,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Brno","65653","Czechia",{"type":72,"coordinates":73},"Point",[74,75],16.60796,49.19522,{"lat":75,"lon":74},[78,79,80],{"name":57,"role":58,"phone":59,"phoneExt":26,"email":60},{"name":62,"role":58,"phone":63,"phoneExt":26,"email":64},{"name":53,"role":54,"phone":26,"phoneExt":26,"email":26},{"type":82,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100644605","comprehensive-perioperative-program-based-on-prehabilitation-nutritional-intervention-and-psychological-support-for-patients-with-locally-advanced-operable-oesophagogastric-cancer-100644605",false,"NCT07671625","Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer","A Comprehensive Preoperative and Postoperative Program Consisting Of Active Physical Therapy, A Comprehensive Nutritional Plan, And Psychological Support For Patients With Locally Advanced, Resectable Cancer Of The Esophagus, Gastroesophageal Junction, and Stomach","OESOFIT","Inclusion Criteria:\n\n* Consent to participate in the study\n* Age ≥ 18 years\n* Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment\n* Resectable disease\n* ECOG performance status 0-2\n* Ability to participate in a fitness program\n* Willingness to follow a nutritional plan and recommendations\n\nExclusion Criteria:\n\n* Disseminated disease","ALL","18 Years",{"count":94,"type":95},60,"ESTIMATED","INTERVENTIONAL",[98],"NA","Perioperative chemotherapy (CHT) or CHT\u002FRT combined with surgery is the standard therapeutic approach for the treatment of locally advanced cancer of the esophagus, gastroesophageal junction (GEJ), and stomach. Comprehensive cancer treatment is associated with high perioperative morbidity and mortality. Serious postoperative complications occur in up to 20-80% of patients undergoing esophagectomy. The impact of nutritional status and overall physical condition on surgical outcomes and overall treatment has been demonstrated many times. The concept of pre-rehabilitation\u002Fpre-optimization, which involves establishing an individualized nutritional plan, monitoring and managing physical activity, and providing comprehensive supportive oncological and psychological care as early as during neoadjuvant CHT or CHT\u002FRT, is a prerequisite for improving perioperative and 30-day postoperative morbidity and mortality.",[101,102,103],"Locally Advanced Esophageal Cancer","Gastroesophageal Junction Cancer","Gastric Cancer",[105,106,107,108,109,110],"autonomic nervous system","physiotherapy","gastric cancer","nutritional intervention","psychologic support","esophageal cancer","2026-06-25",{"date":113,"type":114},"2026-06-26","ACTUAL",{"date":116,"type":114},"2023-05-02",{"date":118,"type":95},"2026-12-31",{"name":5,"class":6},1]