[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cachexia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cachexia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,51,76,102,139,163,189,210,235,258,280,303,324,350,374,398,425,453,478,500,523,547,572,602,628],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100592131","phase-2-a-study-to-learn-about-the-medicine-ponsegromab-in-adults-with-cancer-of-the-pancreas-which-has-spread-and-caused-significant-body-weight-loss-and-fatigue-100592131",false,"NCT06989437","A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue","A Phase 2b\u002F3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma","Key inclusion Criteria:\n\n* Signed Informed Consent Document\n* Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma\n* Cachexia defined by Fearon criteria of weight loss\n* Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy\n* ECOG PS ≤1 with life expectancy of at least 4 months\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake\n* Cachexia caused by other reasons\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification\n* Left ventricular ejection fraction \\\u003C50%\n* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody\n* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients\n* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases\n* Inadequate liver function\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2","ALL","18 Years",{"count":19,"type":20},982,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.",[27,28],"Cachexia","Metastatic Pancreatic Ductal Adenocarcinoma",[30,31,32,33,34,35,36,37],"pancreatic cancer","metastatic cancer","cancer","anorexia","cachexia","weight loss","loss of appetite","fatigue","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2025-10-03",{"date":46,"type":20},"2029-12-10",{"name":48,"class":49},"Pfizer","INDUSTRY",211,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100644326","phase-1-a-study-to-learn-about-the-study-medicine-called-ponsegromab-in-adults-with-lung-cancer-associated-significant-weight-loss-100644326","NCT07663630","A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Weight Loss","AN INTERVENTIONAL, PHASE 1B, DOUBLE-BLIND, RANDOMIZED, SPONSOR-OPEN, 2-ARM STUDY TO INVESTIGATE THE EFFECT OF PONSEGROMAB ON SKELETAL MUSCLE MASS AND PHYSICAL FUNCTION IN ADULT PARTICIPANTS WITH NON-SMALL CELL LUNG CANCER ASSOCIATED CACHEXIA","Key Inclusion Criteria:\n\n* Signed Informed Consent\n* Documented histological or cytologic diagnosis of NSCLC with each of the following:\n\n  1. locally advanced, unresectable, stage III disease (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system); and\n  2. measurable disease at time of screening (assessment per RECIST v1.1); and\n  3. must have completed platinum-based chemotherapy concurrent with radiation therapy, within 7 to 42 days prior to the randomization; and\n  4. no evidence of progression of disease following definitive, platinum-based, concurrent chemoradiation therapy; and\n  5. must be due to receive consolidation immunotherapy with durvalumab for up to 12 months, with the first dose of blinded study intervention to coincide with the first dose of durvalumab +\u002F- 7 days; and\n  6. absence of actional genomic mutations (eg, EGFR, ALK).\n* Cachexia defined by Fearon criteria:\n\n  1. BMI \\\u003C20 kg\u002Fm2 and involuntary weight loss of \\>2% within 6 months prior to screening; or\n  2. Involuntary weight loss of \\>5% over the past 6 months prior to screening irrespective of BMI\n* Participant has been evaluated and determined that available anticachexic treatments have either been administered with no positive effect or the participant is not suitable for these treatments.\n* Participants who are assessed by the investigator to have an ECOG PS ≤1.\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to:\n\n  1. NCI CTCAE Grade 3 or 4 oral mucositis\n  2. Mechanical obstructions interfering with the participant's ability to eat\n* Receiving tube feedings or parenteral nutrition (either total or partial) at the time of screening or randomization.\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification.\n* Cachexia caused by reasons other than NSCLC, as determined by the investigator (eg, severe COPD).\n* Mixed small cell and non-small cell lung cancer histology.\n* Undergoing major surgery within 4 weeks prior to randomization or planned major surgical procedures during the study.\n* History of immune-related adverse event(s) in setting of immunotherapy that required treatment with systemic corticosteroids.\n* Chronic use of systemic corticosteroid.\n* History of any secondary malignancy in the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ.\n* Symptomatic brain metastasis or leptomeningeal disease.\n* Any Grade ≥3 pulmonary disease unrelated to underlying malignancy including, but not limited to:\n\n  1. Severe asthma requiring systemic corticosteroids within 30 days prior to first dose of study intervention or not well controlled with low-dose inhaled corticosteroids\u002Flong-acting beta-2 agonists.\n  2. Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids.\n  3. Clinically severe and\u002For Grade 4 pulmonary emboli within 3 months of the first dose of study intervention. Pulmonary emboli in main or lobar pulmonary arteries are also excluded.\n  4. Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc).\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m².\n* History of severe liver disease or cirrhosis, unrelated to metastatic cancer. LFT abnormalities at the time of screening; confirmed by a single repeat test if deemed necessary: AST or ALT level ≥ 3 x ULN (\\>5 x ULN if liver involvement by the tumor), alkaline phosphatase \\> 3 x ULN (\\>5 x ULN if liver involvement by the tumor and\u002For in case of bone metastases), or total bilirubin level ≥ 1.5 x ULN (For Gilbert's syndrome, direct bilirubin \\> ULN is exclusionary).\n* Left ventricular ejection fraction \\\u003C50% on screening echocardiogram (or MUGA scan).",{"count":59,"type":20},80,[61],"PHASE1","Study to investigate the effect of ponsegromab on skeletal muscle mass and physical function in adult participants with non-small cell lung cancer associated cachexia.",[64,27],"Non-small Cell Lung Cancer (NSCLC)",[66],"non-small cell lung cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue","NOT_YET_RECRUITING","2026-06-17",{"date":70,"type":42},"2026-06-23",{"date":72,"type":20},"2026-07-22",{"date":74,"type":20},"2029-03-29",{"name":48,"class":49},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100572669","early-phase-1-a-phase-i-study-on-evaluating-the-safety-tolerability-pharmacokinetic-characteristics-and-preliminary-efficacy-of-sxrn-plasmid-dna-technique-in-patients-with-advanced-solid-tumors-100572669","NCT06736275","A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors","For Dose-Escalation Phase:\n\n* Inclusion Criteria:\n* male or female, aged 18\\~75 at the time of signing the ICF;\n* patient with advanced solid tumors who have failed\u002Fcannot tolerate previous standard therapies or lack conventional effective therapies;\n* at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* expected survival time ≥12 weeks;\n* lab results and organ function tested within 7 days before the initial infusion meet the criteria below:\n* Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL;2)Platlets (PLT) Count≥90×10\\^9\u002FL; 3)Hemoglobins (Hb) ≥90 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 ≥50 mL\u002Fmin; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤2.5×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g\u002FL.\n* Urine protein ≤2+ (if \\>2+, urine protein shall be collected for 24 hours; total protein ≤1g is acceptable for inclusion).\n* 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* Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* can understand and voluntarily sign the Informed Consent Form (ICF); must be voluntary and able to finish the study program and follow-up tests.\n\nExclusion Criteria:\n\n* Subjects who meet any of the criteria below must not be included:\n* has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail agents within 4 weeks or 5 half-times (whichever is shorter) before the initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).\n* participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.\n* Patients who had undergone or planned to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before initial infusion.\n* unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions with no safety risk as determined by the investigator, such as alopecia, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).\n* with clinically uncontrollable serous effusion (pleural effusion, ascites and pericardio effusion). Conditions may include: moderate or above sized effusion, received within 2 weeks before the selection or plans to receive local treatments (including drainage, peritoneal shunt, and cell-free concentrated ascites reinfusion, and etc.), or effusion obviously increased within 2 weeks after the local treatment and thus needs long-term catherterization. Candidates who meet any of the conditions above, or determined by the investigator as unsuitable, shall not be included.\n* with central nervous system metastasis and show relating symptoms.\n* with a history of other malignant tumors, except for those that have received radical surgery and not relapsed 5 years thereafter, such as carcinoma in situ of cervix, skin basal cell carcinoma, and etc.\n* with a history of immune deficiency diseases, including acquired or congenital immunodeficiency disorders; or a history of organ transplantation, heterogeneous bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n* had (non-infectious) lung inflammation \u002F interstitial lung disease that required steroid treatment within 4 weeks before the initial infusion.\n* with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. severe abnormalty in cardiac rhythm or conduction, such as ventricular arrhythmia requiring clinical intervention, atrioventricular block of II\\~III grade, and etc.;\n  2. cardiac insufficiency of III\\~IV grade as defined by New York Heart Association(NYHA);\n  3. acute coronary syndrome, congestive cardiac failure, aortic dissection, cerebral stroke or other grade 3 or above cardio-cerebral vascular events within 6 months before the initial infusion.\n* with uncontrollable high blood pressure (systolic pressure ≥160 mmHg and\u002For diastolic pressure ≥100 mmHg) after treatment with anti-hypertensive drugs of stable doses.\n* with active chronic hepatitis B (such as, HbsAg or HbcAb positive and HBV DNA ≥ lower limit of detection, active hepatisis C (such as, HCV antibody positive and HCV RNA≥ lower limit of detection), or HIV infection.\n* with active infections within 2 weeks before the initial infusion that require systematic treatment.\n* with a history of active tuberculosis infection within 1 year before the initial infusion.\n* had or has uncontrollable or serious diseases that may interfere with the participation or evaluation in the study, as considered by the investigator;\n* known to be allergic or taking drugs contradictionary to the study drug (Suplussirna) or its excipients.\n* premenopause female candidates (postmenopausal female patients can only be considered infertilewhen they have been postmenopausal for at least 12 months) with positive results in serum pregnancy test; candidates of reproductive age (also including female spouse of reproductive age of male candidates), during the study or within 6 months after the last infusion, who will probably bear children, breastfeed, or are unwilling to cake effective contraceptives, as considered by the investigator.\n* other conditions that are determined by the investigator as unsitable for entering this trial.\n\nFor Expansion Cohort(Randomized, Double-blind, Placebo-controlled Part):\n\n* Inclusion Criteria:\n* Male or female, aged 18 to 75 years at time of signing ICF.\n* Histologically or cytologically confirmed solid tumor.\n* Patients who have failed standard therapy, lack standard therapy, or are in a treatment holiday period (4 weeks) without need for anti-tumor therapy.\n* Diagnosis of cancer anorexia-cachexia according to 2025 CSCO guideline, meeting either (①+②) or (①+③):\n\n  * Involuntary weight loss \\>5% in 6 months; OR weight loss \\>2% with BMI \\\u003C18.5 kg\u002Fm²; OR weight loss \\>2% with reduced muscle mass.\n\n    * Anorexia (VAS ≤70 or FAACT-A\u002FCS-12 score ≤37).\n\n      * CRP \\>5 mg\u002FL.\n* ECOG performance status 0-2.\n* Life expectancy ≥12 weeks.\n* Adequate organ function and laboratory parameters within 7 days prior to first study drug, meeting the same criteria as listed above for the dose-escalation phase (i.e., ANC, platelets, hemoglobin, liver\u002Fkidney function, coagulation, LVEF, etc.).\n* Same informed consent requirement as the dose-escalation phase: able to understand and voluntarily sign the ICF, and willing\u002Fable to complete study procedures and follow-up.\n\nExclusion Criteria:\n\nThe exclusion criteria are the same as those for the dose-escalation phase above, with the following additional or modified criteria:\n\n* Reversible causes of reduced food intake determined by investigator (e.g., mechanical obstruction preventing eating).\n* Use of any medication or therapy for cachexia, anorexia, or weight loss (excluding enteral nutrition support) within 28 days or 5 half-lives (whichever shorter) prior to first study drug, including but not limited to progestins (megestrol acetate, medroxyprogesterone acetate), corticosteroids, anamorelin, cannabinoids, androgens, NSAIDs.\n* Currently receiving tube feeding or parenteral nutrition.\n* Cachexia clearly due to other causes (e.g., severe COPD, AIDS).\n* Hormone therapy judged by investigator to improve cachexia.\n* Central nervous system metastases requiring intervention (instead of \"symptomatic CNS metastases\").\n* Known allergy or contraindication to SXRN or its process impurities (e.g., spectinomycin).\n* Note: For the expansion cohort, the washout period for other investigational drugs is \"4 weeks or 5 half-lives\" (same as dose-escalation phase), and all other exclusion criteria (prior anti-tumor treatments, unresolved toxicity, serous effusion, cardiovascular disease, infections, etc.) apply identically as listed above.","75 Years",{"count":84,"type":20},28,[86],"EARLY_PHASE1","The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.",[89,27],"Advanced Cancer",[91],"micoRNA","2026-05-13",{"date":94,"type":42},"2026-05-15",{"date":96,"type":42},"2024-09-02",{"date":98,"type":20},"2027-12-09",{"name":100,"class":49},"Jiangsu Nutai Biologics Co., Ltd",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":101},"100599366","routine-validation-and-reproducibility-testing-of-laboratory-assays-and-research-techniques-used-for-endocrine-cardiometabolic-and-musculoskeletal-disorder-research-vald-100599366","NCT07083557","Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)","VALD","Inclusion Criteria:\n\n* ≥18 and ≤100 years of age\n* body mass index ≥16.0 and ≤60 kg\u002Fm2\n\nExclusion Criteria:\n\n* \\\u003C18 and \\>100 years of age\n* body mass index \\\u003C16.0 or \\>60 kg\u002Fm2\n* allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians\n* use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay\u002Ftechniques being evaluated\n* engaged in regular structured exercise \\>150 min per week unless needed for validation of the assay\u002Ftechnique being evaluated\n* significant organ system dysfunction or diseases, except those that are sought for validation of the assay\u002Ftechnique being evaluated\n* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay\u002Ftechnique being evaluated\n* pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.",true,"100 Years",{"count":112,"type":20},100,"OBSERVATIONAL","The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.",[116,117,118,119,120,121,122,123,124,125,126,127,128,27],"Obesity and Obesity-related Medical Conditions","Diabetes","Atherosclerotic Disease","Heart Failure","MASH","Sarcopenia","Osteoporosis","Hyperparathyroidism","Hypoparathyroidism","Ischemic Heart Disease","Cystic Fibrosis (CF)","Chronic Kidney Disease(CKD)","Osteopenia","2026-05-05",{"date":131,"type":42},"2026-05-07",{"date":133,"type":20},"2027-01-01",{"date":135,"type":20},"2030-07-01",{"name":137,"class":138},"Bettina Mittendorfer","OTHER",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":101},"100636417","phase-2-nanocrystalline-megestrol-acetate-versus-placebo-for-anorexia-in-patients-with-unresectable-hepatocellular-carcinoma-receiving-tace-combined-with-targeted-and-immunotherapy-100636417","NCT07565415","Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy","A Multicenter, Randomized, Controlled Phase II Clinical Trial of Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy","Inclusion Criteria:\n\n* Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology\n* No previous receipt of immunotherapy and\u002For targeted drug therapy\n* Child-Pugh score ≤ 7\n* At least one measurable lesion per RECIST 1.1 criteria; lesions without prior radiotherapy, cryotherapy or other local treatment\n* Single intrahepatic lesion \\\u003C 10 cm, or fewer than 10 intrahepatic lesions with tumor burden \\\u003C 50%\n* Meet precachexia criteria: non-volitional weight loss ≤ 5% in 6 months, plus systemic inflammation (CRP \\> 5 mg\u002FL) or decreased appetite (FAACT-A\u002FCS-12 score ≤ 37 points)\n* Meet cachexia criteria: accompanied by decreased appetite or systemic inflammation, with either non-volitional weight loss \\> 5% in 6 months or BMI \\\u003C 18.5 kg\u002Fm² plus weight loss \\> 2%\n* Voluntarily participate and sign informed consent\n* Age ≥ 18 years, male or female\n* Able to swallow tablets normally\n* ECOG performance status 0 or 1\n* Life expectancy ≥ 12 weeks\n* Adequate major organ function without blood products or colony-stimulating factors within 14 days\n* Hematology: ANC ≥ 1.5×10⁹\u002FL, Hb ≥ 80 g\u002FL, PLT ≥ 50×10⁹\u002FL\n* Liver function: TBIL ≤ 1.5×ULN, AST\u002FALT ≤ 5.0×ULN, ALB ≥ 28 g\u002FL\n* Coagulation function: INR, PT or aPTT ≤ 1.5×ULN\n* Renal function: SCr ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin\n* Urine protein ≤ 1+ or 24-hour urine protein \\\u003C 1.0 g\n* Cardiac function: LVEF ≥ 50%\n* Females of childbearing potential with negative pregnancy test within 3 days before first dosing\n* Fertile male and female patients agree to effective contraception from screening to 120 days after last study drug\n* HBV\u002FHCV infected patients receive stable antiviral therapy without drug interaction\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases; inadequately controlled metastatic brain or leptomeningeal disease\n* Uncontrolled tumor-related pain\n* Thromboembolic disease, ascites or lower limb edema within 6 months\n* History of other malignancies within 5 years before randomization, except curable low-risk tumors\n* Unresolved adverse toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (CTCAE v5.0), excluding alopecia\n* Pregnant, breastfeeding females or those planning pregnancy during the study\n* Any unstable medical, psychiatric or social condition that may interfere with study participation\n* Positive HIV infection\n* Major surgery within 28 days prior to randomization\n* Severe cardiovascular disease, myocardial infarction, unstable arrhythmia, angina or cerebrovascular events\n* Severe systemic infection within 4 weeks before dosing or active infection requiring systemic anti-infective treatment\n* Impaired gastrointestinal absorption, long-term tube feeding, parenteral nutrition or eating disorders\n* Concomitant use of other appetite-enhancing or weight-stimulating agents\n* Cushing's syndrome, adrenal or pituitary insufficiency, poorly controlled diabetes\n* Uncontrolled hypertension despite oral antihypertensive treatment\n* Esophagogastric varices, severe ulcers, gastrointestinal bleeding, obstruction, perforation or fistula within 6 months\n* Known hypersensitivity to any component of the investigational product\n* Any other condition considered inappropriate for enrollment by the investigator.",{"count":147,"type":20},88,[23],"Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on quality of life, inflammatory markers, nutritional indicators, and psychological stress in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Exploratory Objective: To explore the impact of nanocrystalline megestrol acetate versus placebo on survival benefit in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.",[151,27,152,153],"Hepatocellular Carcinoma (HCC)","Anorexia","Malnutrition","2026-04-27",{"date":156,"type":42},"2026-05-04",{"date":158,"type":20},"2026-06-22",{"date":160,"type":20},"2027-09-01",{"name":162,"class":138},"Nanfang Hospital, Southern Medical University",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":170,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":101},"100618966","phase-1-a-clinical-study-of-nanocrystalline-megestrol-acetate-in-concurrent-chemoradiotherapy-for-locally-advanced-cervical-cancer-100618966","NCT07338487","A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","Eligibility Criteria:\n\n1. Voluntarily sign the written ICF.\n2. Age ≥ 18 years at the time of enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n4. Expected survival period ≥ 6 months.\n5. Histologically or cytologically confirmed locally advanced cervical cancer (Stage IB3\u002FIIA2\u002FIIB-IVA) that is not amenable to complete surgical resection, classified according to the International Federation of Gynecology and Obstetrics (FIGO) staging system.\n6. Scheduled to undergo radical concurrent chemoradiotherapy.\n7. At least one measurable tumor lesion according to RECIST v1.1.\n8. Adequate organ function defined as follows:\n\n   a) Hematology (without any blood component or growth factor support within 7 days prior to initiation of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); ii. Platelet count ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); iii. Hemoglobin ≥ 90 g\u002FL. b) Renal: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin\n   * CrCl will be calculated using the Cockcroft-Gault formula:\n\n   CrCl (mL\u002Fmin) = (140 - age) × weight (kg) × F \u002F (serum creatinine \\[mg\u002FdL\\] × 72) F = 1 for males; F = 0.85 for females ii. Urine protein ≤ 1+ or 24-hour urinary protein quantification \\\u003C 1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤ 1.5 × ULN; for patients with liver metastases or confirmed\u002Fsuspected Gilbert's disease, TBil ≤ 3 × ULN; ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN; iii. Serum albumin (ALB) ≥ 28 g\u002FL. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy and coagulation parameters \\[PT\u002FINR and APTT\\] are within the therapeutic range at screening).\n\n   e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n9. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if urine pregnancy test result is not confirmed negative, a serum pregnancy test will be required, and the serum result shall prevail). If a female patient of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and continue for 120 days after the last dose of study drug; whether to discontinue contraception after this time point should be discussed with the investigator. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose; whether to discontinue contraception after this time point should be discussed with the investigator.\n10. The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be ineligible for this study:\n\n1. Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral nutrition; presence of anorexia nervosa, psychogenic anorexia, or pain-induced feeding difficulties.\n2. Current or planned use of medications that increase appetite or weight, including but not limited to: adrenal corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n3. Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus.\n4. Current radiographic or clinical evidence of gastrointestinal obstruction.\n5. Active autoimmune disease requiring systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids, immunosuppressants). History of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current non-infectious pneumonitis.\n6. Uncontrolled concurrent illnesses including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease\u002Fgastritis, or psychiatric\u002Fsocial conditions that would limit compliance with study requirements or the ability to provide written informed consent.\n7. Within 12 months prior to the first dose: unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA Class II or higher), vascular disease (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia). Within 6 months prior to the first dose: history of esophagogastric varices, severe ulcers, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding.\n8. Within 6 months prior to the first dose: any arterial thromboembolic events, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0 requiring urgent intervention (e.g., pulmonary embolism or intracardiac thrombosis), transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior to the first dose: acute exacerbation of chronic obstructive pulmonary disease. Current hypertension with systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite oral antihypertensive therapy.\n9. History of severe bleeding tendency or coagulopathy; clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing\u002Fexpectorating ≥1 teaspoon of fresh blood or small clots, or blood without sputum; patients with blood-tinged sputum are eligible), epistaxis (excluding minor nasal bleeding and blood-tinged postnasal drip).\n10. Within 4 weeks prior to the first dose: severe infections including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; within 2 weeks prior to the first dose: active infection requiring systemic antimicrobial therapy (excluding antiviral therapy for hepatitis B\u002FC).\n11. Any condition, treatment, or laboratory abnormality that may confound study results, impede complete study participation, or make participation not in the patient's best interest.","FEMALE",{"count":147,"type":20},[61],"Cervical cancer, ranking as the fourth most prevalent malignancy in women globally, presents significant challenges in nutritional management. Approximately 31% of patients develop cancer-related malnutrition\u002Fcachexia, with 10-20% of deaths directly attributable to nutritional depletion. The disease process and its treatment - particularly concurrent chemoradiotherapy (CCRT) - create a destructive cycle through multiple mechanisms. Tumor-derived factors (including activins and myostatin) and inflammatory cytokines (such as TNF-α and IL-6) actively promote muscle and fat catabolism. CCRT toxicity, especially from platinum-based drugs, worsens this condition by inducing mitochondrial dysfunction and accelerating protein degradation, leading to clinically significant sarcopenia. This metabolic disruption has dire consequences, with studies showing severe weight loss during CCRT correlating with a 2.37-fold increase in mortality risk (HR 2.37, p=0.036).\n\nNanocrystalline megestrol acetate (MA) emerges as a promising therapeutic intervention with dual mechanisms of action. Centrally, it modulates D2 receptors to upregulate neuropeptide Y (NPY), effectively stimulating appetite. Peripherally, it suppresses key inflammatory cytokines (IL-6 and TNF-α), thereby reducing systemic inflammation and muscle wasting. Its efficacy is well-established, with endorsement from major oncology guidelines (ASCO, NCCN, ESMO) for cancer cachexia management. A comprehensive meta-analysis of 35 clinical trials involving 4,234 patients demonstrated MA's superiority over placebo, showing significant improvements in appetite (RR 2.2), weight gain (RR 1.6), and quality of life (RR 1.8).\n\nThe nanocrystalline formulation represents a substantial pharmacological advancement over conventional MA. While traditional preparations have limited solubility (2 µg\u002FmL) and require high-fat meals for adequate absorption, the nanocrystalline version (with particles reduced to 26.6 nm) demonstrates 22% greater bioavailability. This translates to clinically meaningful differences: fasting-state peak concentrations increase from 187 ng\u002FmL to 1,133 ng\u002FmL, the time to observable effect shortens from 14 days to just 3 days, and 12-week weight gain improves from 3.5 kg to 5.4 kg (with 40% being lean mass). Dose optimization studies confirm 800 mg\u002Fday as the optimal conventional MA dose, with the nanocrystalline equivalent being 625 mg\u002Fday due to its enhanced bioavailability.\n\nThe proposed clinical investigation will evaluate this intervention in FIGO IB3-IVA cervical cancer patients (n=5) undergoing CCRT. The study employs a two-arm design comparing nanocrystalline MA (625 mg\u002Fday) plus CCRT against CCRT alone. Primary endpoints focus on BMI changes at 8 weeks, with secondary assessments of nutritional status, inflammatory markers, and quality of life measures. This research aims to establish nanocrystalline MA as a means to break the cachexia cycle in cervical cancer treatment, potentially improving both treatment tolerance and survival outcomes.",[175,27],"Locally Advanced Cervical Cancer",[175,177,27,178,179],"Nanocrystalline Megestrol Acetate","Clinical Research","Control Group","2026-04-23",{"date":182,"type":42},"2026-04-24",{"date":184,"type":20},"2026-04-30",{"date":186,"type":20},"2026-12-05",{"name":188,"class":138},"Second Xiangya Hospital of Central South University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":206,"leadSponsor":208,"locationsCount":101},"100633744","phase-1-study-of-the-safety-and-efficacy-of-ds010-in-patients-with-cancer-cachexia-100633744","NCT07530666","Study of the Safety and Efficacy of DS010 in Patients With Cancer Cachexia","Phase I\u002FII Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of DS010 in Patients With Cancer Cachexia","Key Inclusion Criteria:\n\n1. Subjects aged ≥ 18 years at screening;\n2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;\n3. Able to provide written informed consent;\n4. ECOG performance status score of 0, 1, or 2;\n5. Patients with histologically or cytologically confirmed malignant solid tumor;\n6. Cancer cachexia documented in medical records;\n\nKey Exclusion Criteria:\n\n1. History of hypersensitivity or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules composed of monoclonal antibody components;\n2. Presence of reversible decreased food intake, as determined by the investigator;\n3. Receiving tube feeding or parenteral nutrition (total or partial parenteral nutrition) at screening;\n4. Severe gastrointestinal disorders (including esophagitis, gastritis, malabsorption);\n5. Cachexia caused by other reasons;\n6. Currently participating in another investigational drug study, or receipt of another investigational product ;",{"count":197,"type":20},58,[61,23],"A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia",[201,27],"Cancer","2026-04-08",{"date":204,"type":42},"2026-04-15",{"date":184,"type":20},{"date":207,"type":20},"2028-04-30",{"name":209,"class":49},"Dartsbio Pharmaceuticals Ltd.",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100468193","assoc-of-genomic-polymorphisms-with-cancer-cachexia-in-subjects-with-panc-adenocarcinoma-100468193","NCT05376592","Assoc. of Genomic Polymorphisms With Cancer Cachexia in Subjects With Panc Adenocarcinoma","Association of Genomic Polymorphisms With Cancer Cachexia in Subjects With Pancreatic Adenocarcinoma","Inclusion Criteria:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information by the subject in accordance with the practices of the Levine Cancer Institute and Atrium Health. NOTE: HIPAA authorization will be included in the informed consent.\n* Male or female patients age ≥ 18 years at the time of consent\n* Histological or cytological confirmation of pancreatic adenocarcinoma, with a diagnosis of locally advanced unresectable PDAC (LAPC) or metastatic pancreatic adenocarcinoma. LAPC is defined as per NCCN 16. Note: Subject can be enrolled at any time during their cancer course following histologic diagnosis.\n* Able to provide a blood or buccal sample.\n\nExclusion Criteria:\n\n* None",{"count":112,"type":20},"A major complication of pancreatic adenocarcinoma (PDAC) is cancer cachexia (CC) which is a complex syndrome characterized by skeletal muscle mass loss (with or without loss of fat mass) and progressive functional impairment not reversible by conventional nutritional support. It is estimated to occur in over 75% of patients with advanced PDAC, the highest incidence of all solid tumors, and contributes significantly to poor outcomes and mortality. Though there is overlap amongst the pathophysiologic studies evaluating CC in murine models of different tumor types, the high prevalence of CC within gastrointestinal (GI) malignancies and specifically PDAC suggest that dedicated studies evaluating polymorphisms in candidate genes specific to PDAC warrant further evaluation. The collection and analysis of specimens under this study will facilitate the identification and characterization of genomic polymorphisms associated with CC in PDAC patients. Subsequently, this data may help contribute towards diagnostic and therapeutic treatments that may improve patient outcomes.",[220,27],"Pancreas Adenocarcinoma",[222,223,224],"Cancer Cachexia","Wasting Syndrome","Pancreatic Cancer","2026-01-20",{"date":227,"type":42},"2026-01-22",{"date":229,"type":42},"2022-06-17",{"date":231,"type":20},"2031-01",{"name":233,"class":138},"Wake Forest University Health Sciences",2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":101},"100620316","phase-3-nanocrystalline-megestrol-acetate-for-cachectic-stage-locally-advanced-hepatocellular-carcinoma-100620316","NCT07356037","Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma","A Prospective Clinical Study of Nanocrystalline Megestrol Acetate in Combination With Standard Therapy Versus Standard Therapy Alone for Cachectic Stage Locally Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Patients with hepatocellular carcinoma who have not previously received systemic therapy and are confirmed by histological or cytological assessment, as evaluated by the investigator, to be unsuitable or ineligible for curative surgical resection; Barcelona Clinic Liver Cancer (BCLC) stage B-C.\n2. Child-Pugh class A or B7.\n3. Planned to receive interventional therapy in combination with systemic antitumor therapy.\n4. At least one measurable tumor lesion according to mRECIST v1.1.\n5. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon criteria).\n\nExclusion Criteria:\n\n1. Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.\n2. Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.\n3. Patients with acquired immunodeficiency syndrome (AIDS).\n4. Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n5. Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.","85 Years",{"count":244,"type":20},68,[24],"This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with standard therapy alone in improving appetite and body mass index (BMI) during treatment in patients with early-stage or locally advanced hepatocellular carcinoma at the cachexia stage.",[27,248],"Hepatocellular Carcinoma","2026-01-14",{"date":251,"type":42},"2026-01-21",{"date":253,"type":20},"2026-01-10",{"date":255,"type":20},"2027-12-31",{"name":257,"class":49},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100505757","phase-1-a-dose-escalation-study-of-av-380-in-cancer-patients-with-cachexia-100505757","NCT05865535","A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia","A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels","Inclusion Criteria:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent.\n2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.\n3. Patients with cachexia as defined by Fearon criteria:\n\n   1. Weight loss \\> 5% over past 6 months (in absence of simple starvation), or\n   2. BMI \\\u003C 20 kg\u002Fm2 and any degree of weight loss \\> 2%, or\n   3. Sarcopenia and any degree of weight loss \\> 2%\n4. Patients with life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody\n2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.\n3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy\n4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n5. Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV\u002FAIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea\u002Fvomiting, diarrhea, and\u002For obstruction, impairing the patient's ability to eat as determined by the Investigator.\n6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.",{"count":266,"type":20},30,[61],"This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.",[27],"2026-01-07",{"date":272,"type":42},"2026-01-08",{"date":274,"type":42},"2023-06-13",{"date":276,"type":20},"2026-12-31",{"name":278,"class":49},"AVEO Pharmaceuticals, Inc.",12,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":101},"100488646","revolution-surgery-revolution-surgery-100488646","NCT05642819","REVOLUTION Surgery (REVOLUTION Surgery)","Routine Evaluation of People Living With Cancer - Surgery","Inclusion Criteria:\n\nInclusion Criteria (Cancer Resection)\n\n* Patients with cancer (Clinical, histological, cytological or radiological evidence) planned for surgical resection of a malignancy of the oesophagus, stomach, pancreas, colon, or rectum\n* Aged 18-years and over\n* Able to give written informed consent\n\nInclusion Criteria (Healthy Controls)\n\n* Patients identified at surgical clinic as being planned for an open abdominal operation for a non-inflammatory, benign condition (e.g. donor nephrectomy)\n* Aged 18-years and over\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and\u002For investigator\n* Presence of a concomitant inflammatory (e.g., rheumatoid arthritis, inflammatory bowel disease) or muscle wasting condition other than cancer\n* Participants who are pregnant, suffer from claustrophobia or with implanted medical devices (e.g., cardiac pacemaker, metallic foreign bodies, aneurysm clip) would not be able to undergo the additional multiparametric magnetic resonance imaging (MRI)",{"count":288,"type":20},200,"Some people with cancer suffer from muscle wasting, lose weight and feel tired. This process, termed cachexia, is a significant problem and can lead to a reduction in both quality and quantity of life.\n\nCachexia is caused by interactions between the tumour and the patient. Historically, it was considered to be a purely end-stage phenomenon of advanced cancer, however, it is now known that early signs of cachexia can even influence the outcomes of patients with potentially curative pathology, including those planned for a surgical resection.\n\nThis study aims to collect information, from patients who are at risk of cachexia, about body composition, physical activity, quality of life and the body's immune response to cancer. Previously these measures have been most frequently studied in isolation, or at one single time-point, and are therefore likely to give an incomplete picture. A more holistic characterisation of surgical patients at risk of cancer cachexia, across their treatments, is currently lacking.\n\nParticipants with cancer will be recruited to the study from surgical services in the United Kingdom (UK). A small number of 'control' patients without cancer, who are undergoing surgery for a benign condition, will also be recruited for comparison. Those recruited will have their height and weight measured, answer questionnaires about quality of life, undergo assessment of their physical function and levels of activity, have blood taken to analyse markers of inflammation and have their body composition measured by a variety of methods. A subgroup of patients will also undergo an additional magnetic resonance imaging (MRI) scan of their abdomen and thighs. At the time of their operation, participants will also have small biopsies of muscle, fat, tumour and urine taken for biochemical analysis. Patients with cancer, will be asked to return for three follow up appointments during the year after their operation where these assessments will be repeated.",[27,291,292,224,293],"Oesophageal Cancer","Gastric Cancer","Colorectal Cancer","2025-12-01",{"date":296,"type":42},"2025-12-02",{"date":298,"type":42},"2023-10-01",{"date":300,"type":20},"2027-12",{"name":302,"class":138},"University of Edinburgh",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":101},"100603012","body-composition-and-psychosocial-factors-in-ici-treated-cancer-patients-100603012","NCT07130981","Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients","Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Aged 18 years or older\n* Having undergone a CT scan (at the L3 level) prior to treatment\n* No severe mental disorder and able to communicate effectively\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Did not provide written informed consent\n* Patients deemed unsuitable by the physician",{"count":288,"type":20},"Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors",[201,313,314,27],"Psychosocial Functioning","Treatment Side Effects","2025-08-19",{"date":317,"type":42},"2025-08-24",{"date":319,"type":20},"2025-09-01",{"date":321,"type":20},"2026-01-01",{"name":323,"class":138},"Hacettepe University",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":234},"100508345","patient-recorded-indexing-measurements-100508345","NCT05899205","Patient Recorded Indexing Measurements","PRIMs","Inclusion Criteria:\n\n* Age ≥ 18\n* Diagnosed with cancer\n* Planned for curative-intent surgery or neo-adjuvant chemotherapy\n\nExclusion Criteria:\n\n* ASA-classification V,\n* severe liver cirrhosis Child grade C,\n* end stage renal disease requiring dialysis,\n* severe heart disease New York Heart Association class IV,\n* chronic obstructive pulmonary disease (COPD) requiring (home)oxygen therapy,\n* Patients must be \"mobile\". They may not be bedridden or in a wheelchair.",{"count":332,"type":20},300,"Rationale: One of the greatest challenges in the field of cancer treatment is cachexia, a multifactorial syndrome characterized by substantial loss of body weight (muscle and fat mass), leading to progressive functional impairment. Cancer cachexia significantly impairs quality of life and survival as well as treatment outcome. Despite its considerable relevance for the prognosis of cancer patients, the diagnosis of cachexia is problematic. The current consensus definition of cancer cachexia is based on weight loss over the last six months. In practice, this is assessed by subjective reporting by the patient, which is subject to error and bias. Novel technologies enable accurate, standardized, and objective assessment of body weight and physical activity by newly diagnosed cancer patients in the home situation. Because of the increasing implementation of neo-adjuvant treatment strategies that offer an extended time-window for the collection of these data, there is a great opportunity to use this information in risk analyses by treating physicians, optimization of pre-habilitation programs, and in the shared-decision making process with the patient.\n\nObjective: The central aim of the 'Patient-Recorded Indexing MeasurementS' (PRIMS) study is to improve the accuracy of the diagnosis of cachexia in patients with cancer. This aim will be achieved by focusing on two objectives. The primary objectives are to compare self-reported and objectively measured pre-treatment weight change. The secondary objectives are to define host phenotypes and to investigate longitudinal associations between body weight and physical activity patterns.\n\nStudy design: Explorative pilot study\n\nStudy population: Patients ≥18 years old undergoing curative-intent chemotherapy or surgery for cancer. Patients will be included in two referral centers specialized in treatment of patients with upper gastrointestinal, hepatobiliary, pancreatic, colorectal, and ovarian cancer.\n\nMain study parameters\u002Fendpoints: The primary endpoint is body weight change over time. Objectively measured body weight will be compared to subjectively reported body weight change. Their respective association with treatment-related adverse events and survival will be investigated. Survival will be calculated from date of start of treatment until death. Chemotherapy related adverse event will be recorded using the Common Terminology Criteria for Adverse Events. Postoperative adverse events will be scored according to the Clavien-Dindo classification.\n\nSecondary endpoints: The secondary endpoints will be the association between other cachexia-related parameters that are investigated in the study and adverse events \u002F survival. Other parameters include physical activity over time, using accelerometry, baseline physical assessment, anthropometric measurements, body composition, and laboratory results. Besides this, other endpoints that will be assessed are disease-free survival (calculated from the first day of treatment until first recurrence) and response to chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",[27,201,335],"Weight, Body",[337,338,339,340,341,342],"Cancer cachexia","Physical activity","Body weight","Body composition","Functional mobility","Pre-treatment assessment",{"date":317,"type":42},{"date":345,"type":42},"2021-06-01",{"date":347,"type":20},"2027-06-01",{"name":349,"class":138},"Academisch Ziekenhuis Maastricht",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100601176","a-cluster-randomised-controlled-trial-of-a-multimodal-integrated-intervention-for-kidney-cachexia-100601176","NCT07107087","A Cluster Randomised Controlled Trial of a Multimodal Integrated Intervention for Kidney Cachexia","Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) for Kidney Cachexia: a Mixed-methods Feasibility Cluster Randomised Controlled Trial and Process Evaluation","MMIEAD","Inclusion Criteria:\n\n* \\- CKD Stage 5 patients receiving maintenance HD therapy for \\>3 months, have oedema-free weight loss of at least 5% in 12 months or BMI less than 20 kg\u002Fm2, who have self-reported decreased physical function\u002Fmuscle strength and appetite, increased fatigue, who are male or female, aged \\>18 years and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients under 18 years of age Patients within 3 months of initiation of HD (patients in this time frame are generally less clinically stable, many having vascular access procedures performed and with much higher rates of intercurrent events, including death and hospitalisation).\n\nPatients experiencing weight loss due to clinically explainable reasons for example malabsorption or oesophageal blockage.\n\nPatients already receiving chronic anticoagulation therapy or with a history of bleeding with 3 months\u002Factive bleeding issues.\n\nPatients receiving immunosuppressants or immunomodulators. Patients who are pregnant or breast feeding. Patients with a hypersensitivity to any of the constituent components of the omega-3 dietary supplement Patients who have dementia, a psychiatric disorder (who are not treated and stable) or a severe cognitive impairment which would deem them unable to give informed consent.\n\nPatients with expected survival on dialysis of \\\u003C6 months \\[e.g. those with severe heart failure (New York Heart Association ≥3)\\].\n\nPatients for whom dialysis withdrawal is being considered. Patients likely to receive a live-donor transplant or transfer to peritoneal dialysis during the study duration.\n\nPatients with bilateral lower limb amputations. Patients unable to walk without aids or assistance. Patients deemed to be clinically unstable by their treating physician. Patients who are non-English speaking (not having the ability to provide informed consent, read and write English).\n\nPatients who are currently enrolled in any study which involves exercise, fish oil\u002Fomega-3 or have been taking fish oil or omega-3 supplementation in the previous 3 months.\n\nAre not able\u002Fwilling to be involved.",{"count":359,"type":20},40,[361],"NA","This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators.\n\nPatients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalisation and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). We want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia.\n\nPatients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \\& Dietary advice plus routine care) and two have been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. We will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, we will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, we will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.",[27,364],"CKD","2025-07-30",{"date":367,"type":42},"2025-08-06",{"date":369,"type":20},"2025-08-01",{"date":371,"type":20},"2027-08-01",{"name":373,"class":138},"Queen's University, Belfast",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":396,"locationsCount":101},"100595668","enteral-nutrition-with-l-carnitine-for-cachexia-in-non-small-cell-lung-cancer-100595668","NCT07035444","Enteral Nutrition With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer","Enteral Nutrition Supplemented With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):\n\n  1. Weight loss \\>5% in the past 6 months (without active weight loss);\n  2. Body mass index (BMI) \\\u003C20 and weight loss \\>2%;\n  3. Decreased total skeletal muscle index (detected by bioelectrical impedance analysis: \\\u003C7.26 kg\u002Fm² for males; \\\u003C5.45 kg\u002Fm² for females) and weight loss \\>2%; 3.Age ≥18 years; 4.Patients scheduled to receive or currently undergoing chemotherapy; 5.Patients with an expected survival period ≥3 months; 6.Signed written informed consent and able to comply with the study visit schedule and relevant procedures; 7.Sufficient organ function before the first study treatment (no use of any blood components, leukocyte-elevating drugs, or platelet-elevating drugs within 14 days prior to randomization):\n\n  \u003C!-- -->\n\n  1. Absolute neutrophil count ≥1.5×10⁹\u002FL;\n  2. Platelet count ≥100×10⁹\u002FL;\n  3. Hemoglobin \\>90 g\u002FL;\n  4. Serum creatinine \\\u003C1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) calculated by the Cockcroft-Gault formula \\>50 mL\u002Fmin;\n  5. Total bilirubin \\\u003C1.5×ULN (for Gilbert syndrome patients, \\\u003C3×ULN is acceptable);\n  6. AST and ALT \\\u003C2.5×ULN (for patients with liver metastases, ≤5×ULN);\n  7. International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy\n\nExclusion Criteria:\n\n* 1.Patients scheduled for lung cancer surgery within the next 3 months; 2.Patients with uncontrolled hyperglycemia after adequate treatment; 3.Patients allergic to levocarnitine; 4.Patients with contraindications to enteral nutrition, including but not limited to active gastrointestinal bleeding, complete intestinal obstruction, etc.; 5.Patients with diseases severely affecting digestion and absorption, including but not limited to subtotal gastrectomy, history of intestinal surgery, etc.; 6.Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. Myocardial infarction or unstable angina within 6 months before the first drug administration;\n  2. Stroke or transient ischemic attack within 6 months before the first drug administration;\n  3. Hypertension that cannot be controlled after optimal antihypertensive treatment (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n  4. Patients with clinically significant arrhythmia who have been stable for \\>14 days before the first drug administration may be enrolled;\n  5. Congestive heart failure (New York Heart Association \\[NYHA\\] functional classification \\> Class 3; see Appendix VI for details);\n  6. Myocarditis; 7.Patients currently participating in interventional clinical research treatment, or who have received other investigational drugs or devices within 4 weeks prior to randomization; 8.Active tuberculosis or tuberculosis requiring medical intervention at the current stage, including but not limited to pulmonary tuberculosis; 9.Patients with known mental illnesses or substance abuse that may affect compliance with trial requirements, or a history of alcohol abuse; 10.Patients with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results or prevent the subject from participating in the study throughout the process, or where the investigator deems participation not in the subject's best interest; 11.Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, which may lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":382,"type":20},126,[361],"This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy.\n\nStudy Design:\n\nRecruitment: Approximately 126 pathologically confirmed patients meeting the inclusion criteria will be enrolled across four hospitals (Army Characteristic Medical Center, Chongqing Fifth People's Hospital, Chongqing Thirteenth People's Hospital, and Chongqing Qianjiang District Central Hospital). The planned enrollment is 60 patients at Army Characteristic Medical Center, 22 at Chongqing Fifth People's Hospital, 22 at Chongqing Thirteenth People's Hospital, and 22 at Chongqing Qianjiang District Central Hospital.\n\nRandomization: Patients will be randomly assigned in a 1:1 ratio to the control group (63 patients) or the intervention group (63 patients).\n\nInterventions:\n\nControl Group: Receive 500 mL of enteral nutrition solution daily for 12 weeks (84 days).\n\nIntervention Group: Receive 500 mL of enteral nutrition solution containing 4 g of levocarnitine daily for 12 weeks (84 days).\n\nEvaluations:\n\nEfficacy Assessments: Body composition analysis and other evaluations will be conducted at baseline and after ONS treatment with levocarnitine to assess the effectiveness of the intervention.\n\nSafety Assessments: Safety events during the levocarnitine-containing ONS treatment period and within 28 days after neoadjuvant therapy will be collected to evaluate treatment safety.\n\nFollow-up: After chemotherapy, the investigator will determine the optimal adjuvant treatment and follow-up protocols to assess recurrence and survival outcomes.",[386,27],"Non-Small Cell Lung Cancer",[388,389],"L-carnitine","Enteral nutrition","2025-06-15",{"date":392,"type":42},"2025-06-25",{"date":394,"type":20},"2025-06-30",{"date":276,"type":20},{"name":397,"class":138},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":234},"100591887","ckd-cachexia-and-gut-microbiome-100591887","NCT06986265","CKD Cachexia and Gut Microbiome","Association of Cachexia and Gut Microbiome in Dialysis Patients : Investigation of the Interactions With Uremic Toxins and Inflammation.","DYNAMICA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of kidney failure (stage V)\n* Maintenance dialysis for at least 3 months\n* Understanding of the trial procedures and ability to adhere to the trial protocol\n\nExclusion Criteria:\n\n* Severe nonadherence to the dialysis procedure\n* Life expectancy below 1 year\n* Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis)\n* Bariatric surgery\n* Active cancer\n* Pregnancy\n* Antibiotics consumption in the month preceding the inclusion\n* Gastro-intestinal surgery, colonoscopy, or probiotics consumption in the 3 months preceding the inclusion\n* Drugs influencing body composition initiated ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives.\n* Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands...\n* Patients under weight loss drugs : GLP1 agonists, orlistat",{"count":407,"type":20},157,"Cachexia is common in patients with chronic kidney disease (CKD) and is associated with increased morbidity and mortality. Cachexia is a complex syndrome, in which inflammation and retention of uremic toxins are two main contributing factors. In this context, the role of the gut microbiome in CKD cachexia and the potential benefit of increasing the dialysis dose have been poorly explored. Here the investigators propose to study the links between cachexia and the gut microbiome, in association with inflammation and uremic toxins, in dialysis.\n\nThe specific objectives are the followings:\n\n1. Set up a prospective cohort of deeply characterized kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit and at home) and peritoneal dialysis, including evaluation of cachexia, body composition, collection of feces and blood to characterize the gut microbiota, measure serum levels of uremic toxins and inflammatory markers, with a longitudinal follow-up.\n2. To compare cachectic versus non-cachectic dialysis patients in terms of gut microbiota, inflammatory markers, level of uremic toxins, muscle transcriptome, dialysis dose and modality. In a subgroup analysis, the investigators plan to compare the different techniques of dialysis (in-center vs home-hemodialysis vs peritoneal dialysis).",[410,27],"Chronic Kidney Diseases",[34,412,413,414,415],"Protein energy wasting","microbiota","chronic kidney disease","dialysis","2025-05-15",{"date":418,"type":42},"2025-05-22",{"date":420,"type":42},"2025-02-04",{"date":422,"type":20},"2030-12",{"name":424,"class":138},"Université Catholique de Louvain",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":234},"100588338","real-world-study-on-nano-crystalline-megestrol-acetate-for-cachexia-in-tki-treated-advanced-digestive-tumors-100588338","NCT06940102","Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors","A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy","Inclusion Criteria:\n\n* Voluntarily sign a written informed consent (ICF).\n* Age ≥ 18 years at enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification.\n* Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy).\n* Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria).\n* Good organ function determined\n\nExclusion Criteria:\n\n* Gastrointestinal obstruction.\n* Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain.\n* Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases.\n* Major surgery or trauma within the last month.\n* Allergy to any component of the investigational drug.\n* Other conditions deemed unsuitable by the investigator.",{"count":433,"type":20},120,"This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy.",[27,436,292,293,248],"Digestive System Cancer",[438,439,440,441,442,443,444,436],"Megestrol Acetate","Nano-crystalline Megestrol Acetate","Targeted Therapy","Tyrosine Kinase Inhibitors","Prospective Studies","Observational Studies","Antineoplastic Agents","2025-04-15",{"date":447,"type":42},"2025-04-23",{"date":449,"type":42},"2025-03-12",{"date":451,"type":20},"2026-12",{"name":257,"class":49},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":460,"targetDuration":461,"studyType":113,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":101},"100579822","influence-of-sarcopenia-on-the-course-of-the-diseases-100579822","NCT06829290","Influence of Sarcopenia on the Course of the Diseases","Influence of Sarcopenia on the Course of the Diseases - Measured Using Ultrasound and Biochemical Markers","Inclusion Criteria:\n\n* oncological patient in the field of gastrointestinal tumors\n* patients with liver cirrhosis\n* patients attending the intensive care unit\n\nExclusion Criteria:\n\n* patients incapable of consenting\n* patients with congenital muscle diseases",{"count":288,"type":20},"24 Months","Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a form of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but still require further validation. In addition, serological muscle markers could support and simplify diagnostics.\n\nThe aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using ultrasound and biomarkers.",[464,201,27,121,465],"Liver Cirrhosis","Mechanical Ventilation",[467,468],"sarcopenia","ultrasound","2025-02-10",{"date":471,"type":42},"2025-02-17",{"date":473,"type":42},"2024-10-01",{"date":475,"type":20},"2028-10-01",{"name":477,"class":138},"Universitatsmedizin Mainz - 1. Medizinische Klinik",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":101},"100485857","microbiota-and-pancreatic-cancer-cachexia-100485857","NCT05606523","Microbiota and Pancreatic Cancer Cachexia","Can Fecal Microbiota Transplantation of Cachectic Patients with Pancreas Cancer Impair Body Weight Gain in Germ-free Mice? the EXTRA Study","EXTRA","Inclusion Criteria:\n\nPatients with pancreatic cancer (n=12)\n\n* ≥18 years and\n* Newly diagnosed of pancreatic adenocarcinoma (local or metastatic) and\n* Tube feeding or parenteral nutrition ≤ 14 days\n\nCachectic pancreatic cancer patients (n=6)\n\n* Cachexia according to the Fearon criteria 1: involuntary weight loss \\>5% over the last 6 months, or any level of weight loss \\>2% and a BMI \\\u003C20 kg\u002Fm2 or sarcopenia. Sarcopenia will be diagnosed by BIA (fat-free mass index is \\\u003C17 kg\u002Fm2 in men and \\\u003C15 kg\u002Fm2 in women) 81, and not by CT, as it is faster and can be performed at the bedside of the patient. Non-cachectic pancreatic cancer patients (n=6)\n* Normal nutritional state: weight stability (± 2% of habitual weight) over the last 6 months, no anorexia before the diagnosis (appetite rating on a visual analogue scale of 100mm), no known impaired glucose tolerance.\n\nHealthy matched subjects (n=12)\n\n* ≥18 years and\n* BMI between 18.5 and 30 kg\u002Fm2 and\n* Absence of chronic or acute disease and\n* Matching for gender and age (± 5 years) with an included pancreatic cancer patient\n\nExclusion Criteria:\n\n* \\\u003C 18 years or\n* Inability to give consent or\n* Insufficient knowledge of project language (French, German) or\n* Pancreatic adenocarcinoma already treated by chemo- or radiotherapy, or major surgery as duodenopancreatectomy or biliary diversion\n* Known rheumatologic or immunologic diseases\n* Therapeutic antibiotics or immunosuppressive drugs (for instance glucocorticoids, cytostatics, antibodies) in the 30 days preceding the inclusion",{"count":487,"type":20},24,"This monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.",[224,490,27],"Microbiota","2024-12-03",{"date":493,"type":42},"2024-12-06",{"date":495,"type":42},"2022-08-01",{"date":497,"type":20},"2025-04-30",{"name":499,"class":138},"Genton Graf Laurence",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":21,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":521,"locationsCount":234},"100555831","phase-3-olanzapine-for-cancer-related-anorexia-cachexia-syndrome-100555831","NCT06517199","Olanzapine for Cancer Related Anorexia-cachexia Syndrome","Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome","Inclusion Criteria:\n\n* pathologically or cytologically metastatic or locally advanced cancer\n* anorexia and \\>=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia \\>=5\n* ECOG performance status 0-3\n* able to complete questionaire and able to swallow pills\n\nExclusion Criteria:\n\n* receiving chemotherapy or anti-cancer systemic therapy\n* life expectancy longer than 1 month\n* received radiotherapy at head\u002Fneck or thoracic or upper abdomen in the past 2 weeks\n* surgery within 4 weeks\n* pregnancy\n* serum bilirubin \\> 2 mg\u002Fdl or serum Cr \\> 2 mg\u002Fdl\n* current use of olanzapine or other antipsychotic drug\n* known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acute coronary event in the past 6 months",{"count":508,"type":20},138,[24],"Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.",[152,27],[513,514],"cancer anorexia","olanzapine","2024-07-18",{"date":517,"type":42},"2024-07-24",{"date":519,"type":42},"2024-01-22",{"date":251,"type":20},{"name":522,"class":138},"Mahidol University",{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":101},"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",{"count":532,"type":20},50,"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",[201,27,535,536,537],"Cachexia-Anorexia Syndrome","Appetite Loss","Weight Loss","2024-07-16",{"date":540,"type":42},"2024-07-17",{"date":542,"type":42},"2024-02-15",{"date":544,"type":20},"2027-11",{"name":546,"class":138},"University of Cambridge",{"id":548,"slug":549,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":555,"enrollmentInfo":556,"targetDuration":558,"studyType":113,"phases":4,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":101},"100444171","mechanism-of-sarcopenia-in-heart-failure-100444171","NCT05063955","Mechanism of Sarcopenia in Heart Failure","Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients","MUSCLE-CHF","Inclusion Criteria:\n\n1. Ability to provide valid informed consent.\n2. Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.\n\nExclusion Criteria:\n\n1. Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not exclude patients).\n2. Severe musculoskeletal or neurological disability.\n3. Severe lung disease with a forced expiratory volume 1 \\\u003C 40% of predicted. Treatment with anticoagulants (warfarin, apixaban, edoxaban, dabigatran and rivaroxaban) is an exclusion criterion for muscle biopsy. Patients with anticoagulant treatment will be invited to participate in the study without muscle biopsy.\n4. Other comorbidities that prevent the patient from participating in the study examinations as judged by the investigator.","90 Years",{"count":557,"type":20},250,"10 Years","The aim of the study is to provide information on the interaction between socioeconomic factors, daily physical activity, nutrition and lifestyle on loss of muscle mass and muscle function in patients with heart failure.",[119,121,27],[562,121,27],"Heart failure","2023-12-19",{"date":565,"type":42},"2023-12-26",{"date":567,"type":42},"2020-12-02",{"date":569,"type":20},"2033-12-31",{"name":571,"class":138},"Aarhus University Hospital",{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":580,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":101},"100494864","malnutrition-assessment-with-bioelectrical-impedance-analysis-in-gastric-cancer-patients-undergoing-multimodal-treatment-100494864","NCT05723718","MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment","MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study","MOONRISE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)\n3. Stage II - III disease (cT2 cN+ and cT3-T4 cN+\u002F-) based on the 8th edition of TNM classification\n4. Qualification for multimodal treatment by the decision of the multidisciplinary tumor board\n\nExclusion Criteria:\n\n1. Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team\n2. Gastric stump carcinoma\n3. Distant metastasis\n4. Upfront surgery\n5. Other malignancies\n6. Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)",{"count":581,"type":20},125,"The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.",[292,584,153,27],"Gastric Adenocarcinoma",[586,587,588,589,590,34,591,592],"gastric cancer","bioelectrical impedance analysis","body composition","nutritional status","malnutrition","multimodal treatment","tumor regression grade","2023-02-09",{"date":595,"type":42},"2023-02-13",{"date":597,"type":42},"2022-12-20",{"date":599,"type":20},"2028-12-31",{"name":601,"class":138},"Medical University of Lublin",{"id":603,"slug":604,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":21,"phases":611,"briefSummary":612,"conditions":613,"keywords":616,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":101},"100410658","multimodal-program-for-cancer-related-cachexia-prevention-100410658","NCT04627376","Multimodal Program for Cancer Related Cachexia Prevention","Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver","Inclusion Criteria:\n\n1. 18 years old or older\n2. Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)\n3. Participants needing chemotherapy\u002Fimmunotherapy\u002Fhormone therapy\u002Ftarget therapy\n4. Participants must be normal or pre cachectic as defined by the guidelines\n5. Read and understand Greek or English\n\nExclusion Criteria:\n\n1. Haematologic tumors\n2. Parenteral Nutrition\n3. ECOG Performance status \\>2 or Karnofsky Performance Status \\\u003C60%\n4. Participant who can not introduce a family caregiver\n5. Participants in cachexia or refractory cachexia stage as defined by the guidelines below:\n\n   * \\>5% weight loss over the past 6 months (in absence of simple starvation); OR\n   * BMI \\\u003C20 and any degree of weight loss \\>2%; OR\n   * Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \\\u003C14.6 kg\u002Fm²; women \\\u003C11.4 kg\u002Fm²) and weight loss \\>2%\n6. Patients who use complementary therapies (ex-acupuncture)",{"count":610,"type":20},60,[361],"The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.",[614,201,27,153,615],"Neoplasms","Educational Problems",[34,617,618,590],"prevention","management","2022-09-01",{"date":621,"type":42},"2022-09-02",{"date":623,"type":42},"2020-09-24",{"date":625,"type":20},"2026-06",{"name":627,"class":138},"Cyprus University of Technology",{"id":629,"slug":630,"hasResults":11,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":109,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":636,"targetDuration":4,"studyType":21,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":101},"100462875","cancer-associated-muscle-mass---molecular-factors-and-exercise-mechanisms-100462875","NCT05307367","Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms","Identifying Molecular Factors Contributing to Cancer-associated Muscle Mass Loss and Providing Clinical Evidence for Exercise Mechanisms to Functionally Restore Muscle in Cancer","PANACEA","Inclusion Criteria, WP1+WP2X+WP2:\n\n* Men and women at or above the age of 18\n* Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb\u002FIV stage not eligible to concurrent chemo\u002Fradiation therapy as primary treatment\n* Referred for 1st line palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), this goes for WP1 + WP2\n* Referred for palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), for recurrent cancer, this goes only for WP2X.\n* Having a staging\u002Fbaseline CT within 4 weeks of initiation of treatment (PET\u002FCT are also allowed), or a baseline scan planned within the first week of treatment.\n* ECOG Performance Status 0-2\n* Having signed the informed consent form\n\nExclusion Criteria, WP1+WP2X+WP2:\n\n* Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)\n* Local palliative radiotherapy as primary treatment\n* ECOG Performance status \\> 2\n* Physical disabilities excluding physical testing\n* Inability to understand Danish\n* Inability to understand scoring systems\u002Fpatient-reported outcome measures\n\nInclusion Criteria, WP3:\n\n* Men and women above the age of 18\n* Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb\u002FIV stage\n* ECOG Performance Status 0-2\n* Having signed the informed consent form.\n\nExclusion Criteria, WP3:\n\n* Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)\n* ECOG Performance Status \\> 2\n* Physical disabilities excluding physical testing\n* Inability to understand Danish\n* Inability to understand scoring systems\u002Fpatient-reported outcome measures",{"count":637,"type":20},144,[361],"Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of \\>5% within 6 months and it occurs in 50-80% of patients with metastatic cancer.\n\nIt is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown.\n\nNo treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer.\n\nAt a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss.\n\nExercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer.\n\nThe data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem.\n\nThree specific aims will be addressed in corresponding work packages (WPs):\n\n* investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1).\n* find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2).\n* measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3).\n\nThe investigators believe that:\n\n* the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life.\n* lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment.\n* exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.",[27,614,641,642,643,644,645,646,121,647,648,649,650,651,652,653,654,655],"Exercise","Metabolism","Body Composition","Insulin Resistance","Physical Functional Performance","Quality of Life","Caregivers","Adipose Tissue","Muscle, Skeletal","Patient Reported Outcome Measures","Gastrointestinal Microbiome","Proteomics","Lipidomics","Epigenomics","Mitochondria","2022-05-09",{"date":658,"type":42},"2022-05-16",{"date":660,"type":42},"2022-04-01",{"date":662,"type":20},"2028-01-01",{"name":664,"class":138},"University of Copenhagen"]