[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cachexia-anorexia-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cachexia-anorexia-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,68,94,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643563","phase-3-olanzapine-in-the-prevention-and-treatment-of-anorexia-cachexia-syndrome-in-patients-receiving-neoadjuvantpreoperative-chemotherapy-100643563",false,"NCT07633236","Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant\u002FPreoperative Chemotherapy","Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients With Localized and Locally Advanced Tumors Receiving Neoadjuvant\u002FPreoperative Chemotherapy","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG status 0-2\n* Localized\u002Flocally advanced ovarian or gastric cancer requiring neoadjuvant\u002Fpreoperative chemotherapy followed by surgery\n* Ability to consume food\u002Fmedications orally\n\nExclusion Criteria:\n\n* Olanzapine use (\\>4 days) for other indications at enrollment\n* Current use of antipsychotics\u002Fantidepressants\n* Systemic corticosteroid use (\\>7 days within the last 4 weeks)\n* History of psychiatric disorders","ALL",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","The goal of this clinical trial is to learn if olanzapine works to prevent and treat anorexia-cachexia syndrome and appetite loss in cancer patients. The main questions it aims to answer are:\n\nIs prolonged low-dose olanzapine effective and save in:\n\n* Preventing\u002Ftreating weight loss due to anorexia.\n* Controlling nausea\u002Fvomiting.\n* Maintaining anticancer therapy dose intensity?\n\nDoes prolonged low-dose olanzapine improve quality of life in patients receiving neoadjuvant\u002Fpreoperative chemotherapy?\n\nParticipants will:\n\nTake prolonged low-dose olanzapine (2.5 mg\u002Fday) in treatment group or usual diet only in control group until surgical treatment Physical examination, anthropometric assessment, blood tests, quality of life, appetite and nutritional status assessment, abdominal CT, handgrip dynamometry before chemotherapy and after preoperative chemotherapy before surgery Physical examination, adverse events every visit Surgical complications within 30 days after surgery",[25,26,27],"Oncology Patients Receiving Chemotherapy","Cachexia-Anorexia Syndrome","Oncology","RECRUITING","2026-06-03",{"date":31,"type":32},"2026-06-08","ACTUAL",{"date":34,"type":32},"2025-03-28",{"date":36,"type":19},"2027-05-31",{"name":38,"class":39},"Blokhin's Russian Cancer Research Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100604236","early-phase-1-feasibility-study-for-repurposing-ret-inhibitors-100604236","NCT07146893","Feasibility Study for Repurposing RET Inhibitors","Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia","FEATHER","Inclusion Criteria:\n\n* Histologically confirmed and documented locally advanced or metastatic NSCLC, pancreatic ductal adenocarcinoma, or colorectal cancer\n* Patient is currently receiving platinum-based therapy for cancer treatment\n* Patients on stable EPI\n* Written informed consent signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses\n* At least 18 years-of-age at the time of signature of the informed consent form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2\n* Plasma GDF-15 level is at least 1500pg\u002FmL\n* Life expectancy exceeds 4 months, as judged by investigator\n* Cachexia, defined as weight loss of \\>5% body weight in the past 6 months, OR weight loss of \\>2% body weight in the past 6 months with BMI \\\u003C 20\n\nExclusion Criteria:\n\n* ECOG Performance Score of 3 or 4\n* Is pregnant or plans to become pregnant during study duration (if patient is of childbearing potential) or plans to make someone pregnant during study duration.\n* Patient has not experienced significant weight loss (defined as loss of \\>5% body weight in the past 6 months, OR loss of \\>2% body weight in the past 6 months with BMI \\\u003C 20)†\n* Out-of-range laboratory values defined as:\n\n  * Absolute neutrophil count (ANC) \\\u003C1.5 x 109\u002FL\n  * Hemoglobin (Hgb)90 g\u002FL or \\\u003C9 g\u002FdL\n  * Platelets \\\u003C100 x 109\u002FL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases\n  * Total bilirubin \\>1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)\n  * Creatinine \\>1.5 times ULN (patients may enter if creatinine is \\>1.5 x ULN and estimated glomerular filtration rate (eGFR) is \\>30 mL\u002Fmin\u002F1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration equation); confirmation of eGFR is only required when creatinine is \\>1.5 X ULN\n  * International Normalization Ratio (INR) \\>2\n* Ongoing treatment with anti-seizure medications that induce the CYP3A enzyme\n* Presence of active gastrointestinal disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of selpercatinib(e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2)\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n* Presence of other active invasive cancers other than the ones treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.\n* Pneumonitis or QTc prolongation.","18 Years",{"count":51,"type":19},7,[53],"EARLY_PHASE1","The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer, or pancreatic cancer.",[26],[57],"RET inhibitor","NOT_YET_RECRUITING","2026-01-13",{"date":61,"type":32},"2026-01-15",{"date":63,"type":19},"2026-02-26",{"date":65,"type":19},"2028-02-23",{"name":67,"class":39},"University of Oklahoma",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":40},"100610710","phase-1-a-phase-i-clinical-study-evaluating-the-safety-tolerability-pharmacokinetic-characteristics-and-preliminary-efficacy-of-sxrn-injection-in-patients-with-cancer-cachexia-100610710","NCT07231120","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia","Inclusion Criteria:\n\nParticipants must meet all the following criteria for inclusion:\n\n* 1\\. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF);\n* 2\\. Patients with histologically or cytologically confirmed advanced solid tumors, with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n* 3\\. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and referring to Chinese population characteristics, i.e., meeting the following criteria (either ① + ② or ① + ③):\n\n  ① \\>5% involuntary weight loss within the past 6 months; or \\>2% weight loss if BMI \\\u003C18.5 kg\u002Fm²; or \\>2% weight loss in the presence of reduced muscle mass;\n\n  ② Anorexia (VAS score ≤70, or FAACT-A\u002FCS score ≤37);\n\n  ③ CRP \\>5 mg\u002FL;\n* 4\\. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4 hematologic toxicity, or ≥ Grade 3 non-hematologic toxicity) to prior standard therapy, or lack effective conventional treatment options;\n* 5\\. (Phase Ib only) Patients requiring standard anti-tumor drug therapy per CSCO guidelines of advanced pancreatic cancer, non-small cell lung cancer, colorectal cancer, or other eligible solid tumors;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n* 7\\. Life expectancy ≥12 weeks.\n* 8\\. Laboratory test results and organ function assessed within 7 days prior to the first dose must meet the following criteria:\n* Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL;2)Platlets (PLT) Count≥75×10\\^9\u002FL; 3)Hemoglobins (Hb) ≥80 g\u002FL.\n\nNote: the criteria above shall still be maintained within 14 days before the initial infusion, either without the need of blood transfusion, or using supportive treatment including granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 (IL-11), and erythropoietin (EPO), and etc.\n\n* Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥30 mL\u002Fmin; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤3×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g\u002FL.\n* Urine routines: Urine protein ≤2+ (if \\>2+, 24-hour urine protein quantification must be performed, and total protein ≤1 g is required for eligibility).\n* Blood coagulation: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n\nNote: for subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.\n\n* Ultrasonic cardiogram: Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* 9.The participant must be able to understand and voluntarily sign the written Informed Consent Form (ICF); and must be willing and able to comply with all study procedures and follow-up examinations.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria shall be excluded from the study:\n\n* 1\\. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction preventing adequate oral intake;\n* 2\\. Use of any prescription medication intended to improve appetite or mitigate weight loss within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the investigational product, including but not limited to anamorelin, megestrol acetate, cannabinoids, or medical marijuana;\n* 3\\. Patients currently receiving tube feeding or parenteral nutrition support;\n* 4\\. Treatment with any other investigational drug within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the study drug;\n* 5\\. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;\n* 6\\. Hormonal therapy judged by the investigator as potentially to improve the assessment of cachexia-related outcomes.\n* 7\\. Patients who have undergone major surgery or interventional procedures within 4 weeks prior to the first dose, or who are scheduled to undergo such procedures during the trial (excluding tumor biopsy, puncture, etc.);\n* 8\\. Patients with toxicities from previous antitumor therapies that have not yet recovered to ≤ Grade 1 or baseline levels (except for toxicities judged by the investigator as to pose no safety risk, such as alopecia, or asymptomatic hypothyroidism induced by immune checkpoint inhibitors that is stable and only requires thyroid hormone replacement therapy);\n* 9\\. Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion), meeting any of the following criteria: moderate or larger volume, received local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy, etc.) within 2 weeks before screening or scheduled within the next 2 weeks, significant re-accumulation within 2 weeks after local treatment, or requiring long-term catheterization; or judged by the investigator as unsuitable for enrollment;\n* 10.Patients with central nervous system metastases requiring intervention;\n* 11.History of other malignancies, except for those who have undergone curative treatment with no recurrence within 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, etc.);\n* 12.History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;\n* 13.(Non-infectious) pulmonary inflammation\u002Finterstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;\n* 14.History of severe cardiovascular or cerebrovascular diseases, including but not limited to:\n\n  1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;\n  2. Cardiac dysfunction classified as Class III-IV per the New York Heart Association (NYHA) criteria;\n  3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular\u002Fcerebrovascular events within 6 months prior to the first dose;\n* 15.Hypertension uncontrolled by a stable regimen of antihypertensive medication (systolic blood pressure ≥160 mmHg, and\u002For diastolic blood pressure ≥100 mmHg);\n* 16.Active chronic hepatitis B (e.g., HBsAg positive or HBcAb positive with HBV DNA above the lower limit of detection), active hepatitis C (e.g., HCV antibody positive with HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection;\n* 17.Active infection requiring systemic therapy within 2 weeks prior to the first dose;\n* 18.History of active tuberculosis infection within 1 year prior to the first dose;\n* 19.Any other uncontrolled or significant comorbid disease(s), either currently or historically, that by the investigator's judgment may interfere with trial participation or evaluation;\n* 20.Known allergy or contraindication to the investigational product (SXRN injection) or its drug substance process-related impurities (e.g., spectinomycin);\n* 21.For premenopausal female participants (postmenopausal females must be amenorrheic for at least 12 months to be considered of non-childbearing potential): serum pregnancy test as positive, or participants of childbearing potential (including female partners of male participants) who, in the investigator's opinion, are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study and for at least 6 months after the last dose of the investigational product;\n* 22\\. Any other condition that considered by the investigator as to render the patient unsuitable for participation in the study.","75 Years",{"count":76,"type":19},54,[78],"PHASE1","This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.",[26,81],"Solid Tumor Malignancies",[83],"cancer patient with anorexia-cachexia","2025-12-04",{"date":86,"type":32},"2025-12-08",{"date":88,"type":32},"2025-11-17",{"date":90,"type":19},"2026-12-30",{"name":92,"class":93},"Jiangsu Nutai Biologics Co., Ltd","INDUSTRY",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":74,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100600026","phase-2-nano-crystalline-megestrol-acetate-for-anorexia-cachexia-syndrome-in-advanced-lung-cancer-100600026","NCT07092137","Nano-crystalline Megestrol Acetate for Anorexia-Cachexia Syndrome in Advanced Lung Cancer","Nano-crystalline Megestrol Acetate for Anorexia-Cachexia in Advanced Lung Cancer: A Randomized, Double-Blind, Multicenter Study","Inclusion Criteria:\n\nPatients must meet all the following criteria to be eligible for study enrollment:\n\n1. Inclusion criteria for advanced lung cancer:\n\n   1. Patients with histologically or cytologically confirmed locally advanced (Stage ⅢC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that cannot be completely resected surgically or treated with radical chemoradiotherapy, according to the 8th edition of the TNM staging classification for lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification.\n   2. Patients with histologically or cytologically confirmed small cell lung cancer (SCLC) and diagnosed as extensive-stage SCLC based on the 8th edition of AJCC staging or the Veterans Administration Lung Group (VALG) criteria (excluding mixed small cell lung cancer).\n   3. Subjects who have not received prior systemic chemotherapy for metastatic disease. Subjects who received adjuvant\u002Fneoadjuvant chemotherapy or radical concurrent\u002Fsequential chemoradiotherapy with curative intent for non-metastatic disease are eligible if disease progression occurs \\>6 months after the end of the last treatment.\n   4. At least one measurable tumor lesion according to RECIST v1.1.\n2. Criteria for pre-cachexia or cachexia stage:\n\n   1. Pre-cachexia diagnostic criteria (all three must be met):\n\n      * Unintentional weight loss ≤5% in the past 6 months;\n\n        ② Systemic inflammation (CRP \\>5 mg\u002FL);\n\n        ③ Decreased appetite (FAACT-A\u002FCS 12 score ≤37).\n   2. Fearon diagnostic criteria for cachexia stage (any one of the following combined with decreased appetite \\[FAACT-A\u002FCS 12 score ≤37\\] or systemic inflammation \\[CRP \\>5 mg\u002FL\\]):\n\n      * Unintentional weight loss \\>5% in the past 6 months; ② Weight loss \\>2% when BMI \\\u003C18.5 kg\u002Fm².\n3. General inclusion requirements:\n\n   1. Good compliance and signed informed consent form.\n   2. Age 18-75 years, regardless of gender.\n   3. ECOG performance status 0-2.\n   4. Life expectancy ≥6 months.\n   5. Good organ function:\n\n      • Hematological: Neutrophils ≥1.5×10⁹\u002FL, hemoglobin ≥9 g\u002FdL, platelets ≥100×10⁹\u002FL.\n\n      • Liver function: Bilirubin ≤1.5×ULN (patients with known Gilbert disease and serum bilirubin ≤3×ULN are eligible); AST and ALT ≤2.5×ULN (if liver metastasis is present, AST and ALT ≤5×ULN); alkaline phosphatase ≤3×ULN (if liver or bone metastasis is present, ALP ≤5×ULN); albumin ≥3 g\u002FdL.\n      * Coagulation function: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤1.5×ULN.\n      * Renal function: Creatinine clearance rate ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n      * Urine protein ≤1+ or 24-hour urine protein \\\u003C1.0 g.\n      * Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.\n   6. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first drug administration (if the urine test is inconclusive, a serum test is required, with the serum result as the standard). If a female patient of childbearing potential has sexual activity with an unsterilized male partner, she must use an acceptable contraceptive method from screening and agree to continue contraception for 120 days after the last administration of the study drug. Whether to discontinue contraception after this period should be discussed with the investigator. Male patients who are not sterilized and have sexual activity with female partners of childbearing potential must use effective contraception from screening to 120 days after the last administration. Whether to discontinue contraception after this period should be discussed with the investigator.\n\nExclusion Criteria:\n\n* (1) Cancer-specific exclusion criteria:\n\n  a) Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) confirmed by CT or magnetic resonance (MRI) evaluation during screening and prior imaging. Patients who have received treatment for brain or leptomeningeal metastases, have been stable for ≥2 months, and have discontinued systemic hormonal therapy (\\>10 mg\u002Fd prednisone or equivalent) \\>4 weeks before randomization may participate.\n\n  b) Uncontrolled tumor-related pain. c) Thromboembolic disease, ascites, or lower limb edema within the past 6 months.\n\n  d) History of malignant tumors other than lung cancer within 5 years before randomization, except for malignancies with negligible risk of metastasis or death \\[e.g., expected 5-year overall survival rate \\>90%\\] and expected to be cured after treatment, such as appropriately treated cervical in situ carcinoma, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.\n\n  e) Unresolved toxicity from prior antitumor therapy, defined as failure to recover to NCI CTCAE v5.0 grade 0 or 1 (except alopecia) or to the levels specified in the inclusion\u002Fexclusion criteria.\n\n  (2) General medical exclusion criteria:\n  1. Women who are pregnant, lactating, or planning to become pregnant during the study.\n  2. Patients with hepatitis B (known HBsAg-positive and HBV DNA ≥1000 cps\u002Fml or 200 IU\u002Fml or ≥ the upper limit of normal at each study center) or hepatitis C:\n\n     ● For patients with a history of HBV infection, HBV DNA testing must be performed, and they are eligible only if HBV DNA is negative (HBV DNA \\\u003C1000 cps\u002Fml or 200 IU\u002Fml or below the upper limit of normal).\n     * Among patients with positive HCV antibody, only those with negative HCV RNA by polymerase chain reaction (PCR) may participate.\n  3. Patients with positive human immunodeficiency virus (HIV) test results.\n  4. Receipt of major surgery (excluding diagnostic surgery) within 28 days before randomization, or expected to undergo major surgery during the study.\n  5. Significant cardiovascular diseases, such as heart disease defined by the New York Heart Association (class II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C50% must receive the optimal stable treatment regimen as determined by their attending physician, with consultation from a cardiologist if necessary.\n  6. Severe infection within 4 weeks before the first drug administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before the first drug administration (excluding antiviral therapy for hepatitis B or C).\n\n     (3) Medication-related exclusion criteria:\n\n  \u003C!-- -->\n\n  1. Any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, uncontrollable vomiting; patients with difficulty in food intake or requiring enteral or parenteral nutrition support; anorexia nervosa, anorexia due to mental illness, or difficulty in eating due to pain.\n  2. Current or planned use of other appetite or weight-increasing medications, such as adrenal corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n  3. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes; current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive treatment.\n  4. History of esophageal-gastric varices, severe ulcers, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first drug administration.\n  5. Known allergy to any component of the study drug.\n  6. Other circumstances deemed unsuitable by the investigator.",{"count":102,"type":19},116,[104],"PHASE2","Patients with advanced lung cancer are a high-risk population for cancer-related anorexia-cachexia syndrome (CACS). Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and progression of CACS. CACS seriously affects the quality of life of patients with advanced lung cancer, significantly shortens the overall survival (OS) and progression-free survival (PFS), forming a vicious cycle. A number of previous studies have shown that combined supportive therapies such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy for advanced tumor patients is a clinically meaningful and feasible treatment model in clinical practice. However, the efficacy and optimal treatment timing of combination with current first-line immunochemotherapy regimens remain unclear. Although mechanistic studies have shown that anti-cachexia therapy may synergistically enhance the efficacy of immunotherapy, relevant clinical research evidence is lacking.\n\nTherefore, this study hypothesizes that the combination of first-line immunochemotherapy regimen and nano-crystalline megestrol acetate can improve the clinical benefits of patients with advanced lung cancer. It is planned to enroll patients with advanced lung cancer who present with anorexia-cachexia, and administer nano-crystalline megestrol acetate intervention (nano-crystalline megestrol acetate or its placebo control) during first-line immunochemotherapy. The changes in body weight relative to the baseline, as well as the impact on survival benefits and quality of life of patients, will be detected. In China, megestrol acetate is mainly available in two dosage forms: oral suspension and dispersible tablets. The oral suspension of megestrol acetate adopts nano-crystal technology (referred to as nano-crystalline megestrol acetate), which reduces the particle size of megestrol acetate and improves bioavailability. Previous randomized controlled studies have shown that it is superior to non-nano-crystal dosage forms in improving body weight.",[107,26],"Lung Cancer","2025-07-27",{"date":110,"type":32},"2025-07-29",{"date":112,"type":19},"2025-10-10",{"date":114,"type":19},"2027-10-10",{"name":116,"class":39},"Guangzhou Institute of Respiratory Disease",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":40},"100524763","neurobehavioural-and-cognitive-changes-in-cancer-cachexia-cancog-100524763","NCT06112964","Neurobehavioural and Cognitive Changes in Cancer Cachexia (CANCOG)","Understanding the Impact on CANcer on Neurobehavioral Mechanisms and COGnition in Cachexia (CANCOG)","CANCOG","Inclusion Criteria:\n\nGeneral inclusion criteria for all groups:\n\n* Written informed consent\n* Aged 18 years or over\n* Willing and able to comply with study procedures and visits\n\nAdditional inclusion criteria for participants with cancer:\n\n* Histological or cytological diagnosis of cancer or confirmed non-intracranial malignancy on imaging.\n* Unintended documented weight loss of \\>5% body weight in 6 months which is felt to be cancer related, OR patient reported weight loss and\u002For change in appetite\n\nExclusion Criteria:\n\nGeneral exclusion criteria for all groups:\n\n* Non-fluent English speaker\n* Active infection, as determined by the investigator based on clinical symptoms and \u002F or fever and \u002F or requirement for antibiotics\n* Women, who are pregnant, plan to become pregnant or are lactating.\n* MRI contraindication\n* A significant acute, chronic or psychiatric condition which in the judgement of the investigator would place the volunteer at undue risk or interfere with the study\n* Metabolically or clinically unstable on day of study visit\n* Artificial nutrition\n* Taking medications which, as determined by the investigator, may affect appetite or cognition, or otherwise affect completion of study tasks.\n* Weight or body circumference above upper threshold for MRI scanner (220kg)\n* Unresolved obstructive gastrointestinal (GI) lesion\n\nAdditional exclusion criteria for participants with cancer:\n\n• Intracranial cancer or metastatic intracranial involvement of cancer\n\nAdditional exclusion criteria for healthy volunteers:\n\n* Have, or be recovering from, any form of cancer\n* Unintentional weight loss of \\>5% body weight or unexplained loss of appetite",true,{"count":127,"type":19},50,"OBSERVATIONAL","The goal of this observational study is to to look for changes within the brain, and changes in body-to-brain signals in people with cancer and people who do not have cancer. The main questions it aims to answer are:\n\n1. Are there differences in areas of the brain known to be related to appetite control, food reward and motivation, between participants with cancer related weight loss and healthy volunteers\n2. Do responses to questionnaires and computer based tasks suggest participants with cancer related weight loss have reduced appetite and reduced motivation to eat compared to healthy volunteers, and if so, do questionnaires suggest that this is associated with any other symptoms?\n\nResearchers will compare the structure and blood flow in relevant areas of the brain using MRI images between participants with cancer related weight loss and healthy volunteers. Participants will complete questionnaires and computer based tasks to allow researchers to assess areas of the brain which become more active in response to different stimuli. Some computer based tasks will be performed during the MRI scan. This is called functional MRI.\n\nA further objective is to obtain an archive of blood samples which will be stored securely for future analysis if relevant hormones or analytes are identified that may be relevant to metabolism or body composition",[131,132,26,133,134],"Cancer","Cachexia","Appetite Loss","Weight Loss","2024-07-16",{"date":137,"type":32},"2024-07-17",{"date":139,"type":32},"2024-02-15",{"date":141,"type":19},"2027-11",{"name":143,"class":39},"University of Cambridge"]