[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607188":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":59,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":26,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","Placebo + standard chemotherapy + ICIs (PD-1\u002FPD-L1 inhibitors. The placebo was administered at the same dose and on the same schedule as the JK-5G group.",[13],"Dietary Supplement: Placebo, 2.5 g per dose, three times per day",{"label":15,"type":16,"description":17,"interventionNames":18},"JK-5G postbiotics group","EXPERIMENTAL","JK-5G + standard chemotherapy + ICIs (PD-1\u002FPD-L1 inhibitors). The intervention period for JK-5G spanned 90 days, covering four 21-day chemotherapy cycles, with a dosage of 2.5 g administered three times daily.",[19],"Dietary Supplement: Postbiotics, 2.5 g per dose, three times per day",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Postbiotics, 2.5 g per dose, three times per day","Postbiotics oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles).",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo, 2.5 g per dose, three times per day","Placebo made of cyclodextrine, oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles).",[9],[32],{"name":33,"affiliation":5,"role":34},"Hongxia Xu","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Hongxia Xu, PhD, MD","CONTACT","+86 23 68729640","hx_xu2015@163.com",[42],{"facility":5,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Chongqing","Chongqing Municipality","400042","China","CN",{"type":49,"coordinates":50},"Point",[51,52],106.55771,29.56026,{"lat":52,"lon":51},[55],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":57,"investigatorFullName":33,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Director of the Department of Clinical Nutrition",[60,62,64,67,69,71,73,75,78,80],{"name":61,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":63,"class":6},"The First Hospital of Jilin University",{"name":65,"class":66},"Fujian Cancer Hospital","OTHER_GOV",{"name":68,"class":6},"Zhongnan Hospital",{"name":70,"class":6},"National Cancer Center, China",{"name":72,"class":6},"Affiliated Hospital of Jiangnan University",{"name":74,"class":6},"Jiangsu Provincial People's Hospital",{"name":76,"class":77},"The First Affiliated Hospital of Henan University","UNKNOWN",{"name":79,"class":6},"Shanghai Changzheng Hospital",{"name":81,"class":6},"Zhengzhou University","100607188","postbiotics-ameliorate-cachexia-in-patients-with-non-small-cell-lung-cancer-100607188",false,"NCT07185308","Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer","Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender.\n\n   \\-\n2. Patients with histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) classified as stage III-IV according to the 9th TNM edition of IASLC, who are either currently receiving or have completed chemotherapy combined with immunotherapy.\n\n   \\-\n3. Cachexia was diagnosed according to the international consensus criteria: involuntary weight loss \\>5 % within 6 months preceding screening, or BMI \\\u003C20 kg\u002Fm² combined with \\>2 % involuntary weight loss within the same period.\n\n   \\-\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 4 months.\n\n   \\-\n5. Prior to the first dose of study treatment, adequate organ function must be documented (no blood products, granulocyte-colony-stimulating factors, or thrombopoietic agents within 14 days before randomisation): 1) Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;2)Platelet count ≥ 100 × 10\\^9\u002FL; 3) Haemoglobin \\> 90 g\u002FL; 4) Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault) \\> 50 mL\u002Fmin; 5) Total bilirubin \\\u003C 1.5 × ULN (\\\u003C 3 × ULN in Gilbert's syndrome) ;6) AST and ALT \\\u003C 2.5 × ULN (≤ 5 × ULN if hepatic metastases present); 7) INR and aPTT ≤ 1.5 × ULN unless the participant is on therapeutic anticoagulation; 8) Left-ventricular ejection fraction (LVEF) \\> 50 %\n\n   \\-\n6. Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention.\n\n   \\-\n7. Participants must demonstrate high adherence to the study protocol.\n\n   \\-\n8. Gastrointestinal function score of \\\u003C 5.\n\nExclusion Criteria:\n\n1. Current presence of reversible causes of reduced food intake (e.g., oral mucositis or mechanical obstruction).\n\n   \\-\n2. Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization.\n\n   \\-\n3. Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV\u002FAIDS).\n\n   \\-\n4. Major surgery within 4 weeks prior to randomization or major surgery planned during the study period.\n\n   \\-\n5. Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization.\n\n   \\-\n6. Use of any appetite- or weight-enhancing agent within 30 days before randomisation, including anamorelin, megestrol acetate, cannabinoids, olanzapine, or mirtazapine.\n\n   \\-\n7. Use of antibiotics or probiotic-containing medications\u002Ffoods within 2 weeks prior to randomization.\n\n   \\-\n8. Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization.\n\n   \\-\n9. Pregnant or lactating women.\n\n   \\-\n10. Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.\n\n    \\-\n11. Individuals who lack full legal capacity or whose legal capacity is restricted.\n\n    \\-\n12. Any medical condition that could interfere with the interpretation of study results or increase the participant's risk in the opinion of the investigators.\n\n    \\-\n13. Participation in any other clinical trial.\n\n    \\-\n14. Gastrointestinal function score of ≥ 5.","ALL","18 Years",{"count":92,"type":93},150,"ESTIMATED","INTERVENTIONAL",[96],"NA","This study aims to evaluate the efficacy of the oral postbiotic preparation JK-5G in improving body weight among patients with non-small-cell lung cancer (NSCLC)-related cachexia. By means of a randomized controlled trial, we will compare the between-group difference in body-weight changes between the JK-5G and placebo arms to clarify its nutritional therapeutic benefit.",[99],"Cachexia; Cancer",[101,102,103],"Non-small-cell lung cancer","Cachexixa","Postbiotics","NOT_YET_RECRUITING","2025-09-22",{"date":107,"type":108},"2025-09-25","ACTUAL",{"date":110,"type":93},"2025-11-01",{"date":112,"type":93},"2026-12-31",{"name":5,"class":6},1]