[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635607":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":47,"centralContacts":52,"locations":58,"responsibleParty":75,"collaborators":29,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":29,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":29,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":108,"whyStopped":29,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutritional Therapy Plus Glucocorticoid","EXPERIMENTAL","Participants receive Spirulina-Bifidobacterium capsules 1080 mg orally twice daily, fish oil-grape seed-blueberry soft capsules 1200 mg orally twice daily, and Ganoderma spore oil 800 mg orally twice daily, in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), until pneumonitis resolution, intolerance, or death.",[13,14,15,16],"Dietary Supplement: Spirulina-Bifidobacterium capsule","Dietary Supplement: Fish oil-grape seed-blueberry soft capsule","Dietary Supplement: Ganoderma spore oil","Drug: Methylprednisolone",{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo Plus Glucocorticoid","PLACEBO_COMPARATOR","Participants receive matching placebo capsules (identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products) in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), tapered until symptoms and imaging improve and then discontinued.",[16,22],"Other: Matching placebo",[24,30,34,38,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","Spirulina-Bifidobacterium capsule","1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Fish oil-grape seed-blueberry soft capsule","1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Ganoderma spore oil","800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"DRUG","Methylprednisolone","Dose and tapering schedule per investigator assessment, referencing NCCN Guidelines 2025 version 1 for immune-related pneumonitis, continued until clinical and radiologic improvement and then tapered to discontinuation.",[9,18],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Matching placebo","Oral placebo capsules identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products, administered to maintain blinding and control for non-specific effects.",[18],[48],{"name":49,"affiliation":50,"role":51},"Chengzhi Zhou, MD","The First Affiliated Hospital of Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},"Fei Wang","CONTACT","+86 18355293991","doctorlzk@163.com",[59],{"facility":60,"status":29,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"The First Affiliated Hospital of Guangzhou Medical University, Department of Pulmonary Oncology","Guangzhou","Guangdong","510120","China","CN",{"type":67,"coordinates":68},"Point",[69,70],113.25,23.11667,{"lat":70,"lon":69},[73,74],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},{"name":49,"role":51,"phone":29,"phoneExt":29,"email":29},{"type":51,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Zhou Chengzhi","Principal Investigator","100635607","nutritional--usual-corticosteroids-randomized-trial-for-immune-related-pneumonia---therapeutic-utilization-evaluation-100635607",false,"NCT07554885","Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation","A Single-Center, Open-Label, Randomized Controlled Clinical Trial Comparing Nutritional Therapy (Spirulina-Bifidobacterium Capsules, Fish Oil-Grape Seed-Blueberry Soft Capsules, and Ganoderma Spore Oil) Combined With Standard Glucocorticoid Regimen Versus Standard Glucocorticoid Regimen Alone in the Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis","Inclusion Criteria:\n\n1. Voluntary participation with full understanding of the study and signed informed consent form.\n2. Age 18 to 75 years (inclusive) on the day of informed consent signing.\n3. Histologically or cytologically confirmed malignancy.\n4. Received at least one cycle of immune checkpoint inhibitor therapy.\n5. Grade 3-4 immune-related pneumonitis (per CTCAE v5.0 and radiologic grading).\n6. ECOG performance status 0-2, with expected survival of more than 3 months.\n7. Adequate organ function based on laboratory results (without transfusion, apheresis, erythropoietin, or granulocyte colony-stimulating factor support within 14 days before the first dose). Women of childbearing potential must have a negative serum pregnancy test within 7 days before first dose.\n\nExclusion Criteria:\n\n1. Severe cardiac, cerebrovascular, renal, hematologic, or other serious systemic disease, including: NYHA Class III-IV heart failure; acute myocardial infarction or unstable angina within 6 months; severe post-stroke functional impairment (mRS greater than or equal to 3); progressive neurodegenerative disease; Child-Pugh Class B or C liver disease or acute liver failure; CKD stage 4-5 (eGFR less than 30 mL\u002Fmin\u002F1.73 m2) or requiring dialysis; absolute neutrophil count less than 1.5 x 10\\^9\u002FL, platelet count less than 50 x 10\\^9\u002FL, or Grade 3 or higher anemia (Hb less than 8 g\u002FdL).\n2. Severe allergic constitution or contraindications to the study treatment.\n3. Significant psychiatric or psychological disorder, or doubts about the treatment plan.\n4. Investigator judgment that the patient is unsuitable for the trial (e.g., poor follow-up adherence, refusal of supportive care).\n5. Use of anti-tumor traditional Chinese medicine within 14 days before first dose.\n6. History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n7. Severe acute or chronic infection.\n8. Known alcohol or drug abuse history.\n9. Pregnancy or breastfeeding.\n10. Use of antibiotics, probiotic food, or microecological preparations within 2 weeks before enrollment.\n11. Prior treatment-related lung injury: (a) targeted-therapy-related pulmonary toxicity (prior EGFR-TKI, ALK inhibitor, VEGF inhibitor, or antibody-drug conjugate causing interstitial lung disease or pneumonitis that has not fully resolved, with radiologic fibrosis or persistent functional impairment); (b) thoracic radiation-related lung injury (radiation pneumonitis or radiation fibrosis with irreversible CT findings).\n12. Use of another investigational drug within 28 days before first dose that, per investigator judgment, would interfere with evaluation of study treatment.\n13. Gastrointestinal disorder precluding oral administration.","ALL","18 Years","75 Years",{"count":89,"type":90},60,"ESTIMATED","INTERVENTIONAL",[93],"NA","This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft capsules, and Ganoderma spore oil) to standard glucocorticoid therapy improves outcomes in patients with Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP), compared with standard glucocorticoid therapy alone.\n\nA total of 60 patients with malignancies who develop Grade 3-4 CIP (per CTCAE v5.0) after at least one cycle of immune checkpoint inhibitor therapy will be randomized 1:1 to the experimental or control arm. The primary endpoints are time to pneumonitis downgrading and the proportion of patients achieving downgrading at 3 months.",[96,97,98],"Immune Checkpoint Inhibitor-Related Pneumonitis","Drug-Related Side Effects and Adverse Reactions","Neoplasms",[100,101,102,103,104,105,106,35,107],"Immune checkpoint inhibitor","Pneumonitis","Immune-related adverse events","Glucocorticoids","Spirulina","Bifidobacterium","Grape seed proanthocyanidin","Antioxidant","NOT_YET_RECRUITING","2026-05-21",{"date":111,"type":112},"2026-05-26","ACTUAL",{"date":114,"type":90},"2026-04",{"date":116,"type":90},"2029-10",{"name":5,"class":6},1]