[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-cachexia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-cachexia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,96,124,146,172,208,229,260,292,320],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100641573","cachexia-and-gut-microbiota-in-patients-with-breast-cancer-receiving-home-care-100641573",false,"NCT07653698","Cachexia and Gut Microbiota in Patients With Breast Cancer Receiving Home Care","Evaluation of Cancer Cachexia and Analysis of Gut Microbiota in Patients With Breast Cancer Receiving Home Care","GM_ANT","Inclusion Criteria\n\n* Female patients with Breast Cancer (BC)\n* Age ≥ 18 years\n* Able to understand the study objectives and provide written informed consent\n* Able to speak and understand Italian\n\nExclusion Criteria\n\n* Antibiotic treatment within the previous 2 weeks\n* Use of probiotic supplements within the previous month\n* Artificial nutrition (enteral or parenteral)\n* Severe dysphagia, intestinal obstruction, or impaired gastrointestinal function\n* Diagnosis of dementia or cognitive impairment preventing understanding of the study information and\u002For provision of informed consent\n* Severe organ failure\n* Refusal to participate For the interventional phase: refractory cachexia and\u002For life expectancy of less than 6 weeks","FEMALE","18 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the possible association between cancer cachexia and Gut Microbiota (GM) in patients with Breast Cancer (BC) cared at home.\n\nCancer cachexia is a multifactorial condition causing weight loss, muscle loss, and reduced physical strength in people with cancer. Moreover, the study will also analyze whether different stages of cachexia are linked to changes in the GM.\n\nThe study will also explore whether a supplementation with a probiotic mixture for twelve weeks is associated with changes in the GM and participants' nutritional and clinical condition.\n\nThe effect of the probiotic mixture (experimental group) will be compared with a placebo (control group) to evaluate whether changes in the GM and in cachexia-related measures differ between the two groups.\n\nParticipants will:\n\n* Provide blood, stool, and urine samples to study the GM and biological markers.\n* Answer questionnaires about symptoms and quality of life.\n* Undergo assessments of nutritional status and body composition.\n\nParticipants eligible for the intervention will take either a probiotic mixture or a placebo for twelve weeks.\n\nAll study procedures will take place during home visits as part of the participants' regular home care program.",[27,28],"Breast Cancer","Cancer Cachexia",[27,30,31,32,33,34],"Cancer cachexia","Gut Microbiota","Palliative Care","Probiotic Mixture","Dysbiosis","NOT_YET_RECRUITING","2026-06-16",{"date":38,"type":39},"2026-06-17","ACTUAL",{"date":41,"type":21},"2026-06-01",{"date":43,"type":21},"2028-08-31",{"name":45,"class":46},"Fondazione ANT Franco Pannuti ETS","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100643710","effects-of-dietary-supplementation-with-omega3-fatty-acids-fish-oil-and-progressive-resistance-training-on-skeletal-muscle-status-in-gynaecological-gastrointestinal-and-urological-cancer-patients-100643710","NCT07643558","Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients","SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids\u002F Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients","SUPPORT","Inclusion Criteria:\n\n* Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages\n* Women and men aged 18 years or older\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Bone metastases or skeletal involvement associated with a high risk of fracture\n* Pregnant or breastfeeding women\n* Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent\n* Participation in other exercise and\u002For nutritional intervention studies within the previous 3 months\n* Current use of fish oil supplements\n* Severe cardiovascular disease, NYHA class IV","ALL",{"count":57,"type":21},288,[24],"Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.\n\nIn addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.\n\nThe aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.",[28,61,62,63,64,65],"Omega 3","Resistance Training","Cancer","Muscle Wasting","Systemic Inflammation",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Resistance training","Progressive resistance exercise","Exercise therapy","Supportive cancer care","Nutritional intervention","Protein-rich nutrition","Nutritional supplementation","Omega-3 fatty acids","Eicosapentaenoic acid (EPA)","Docosahexaenoic acid (DHA)","Fish oil supplementation","Physical performance","Quality of life","Fatigue","Appetite","Patient-reported outcomes","Randomized placebo-controlled trial","Cachexia risk","RECRUITING","2026-06-08",{"date":88,"type":39},"2026-06-11",{"date":90,"type":39},"2026-01-01",{"date":92,"type":21},"2029-10",{"name":94,"class":46},"University of Erlangen-Nürnberg Medical School",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":95},"100582864","phase-1-a-study-of-jmt203-in-patients-with-cancer-cachexia-100582864","NCT06868849","A Study of JMT203 in Patients With Cancer Cachexia","A Phase Ia\u002FII, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Voluntarily participate in the study and sign the informed consent form;\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Voluntarily participate in the study and sign the informed consent form;\n3. Malignant solid tumors confirmed histologically or cytologically, with ongoing or completed anti-tumor treatment, and no significant tumor progression within 28 days prior to the first drug administration，and the investigator estimates that the participant will not require a switch to another anticancer therapy due to disease progression during the first treatment cycle (21 days). For the Phase II portion:\n\n   * Cohort A (participants with colorectal cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected second-line standard anticancer therapy, with no more than 5 cycles of second-line therapy, and not suitable for immune checkpoint inhibitors.;\n   * Cohort B (participants with pancreatic cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected first-line standard anticancer therapy, with no more than 3 cycles of first-line therapy, and not suitable for targeted therapy.;\n   * Cohort C (participants with cachexia from other solid tumors): Currently receiving or have completed investigator-selected standard anticancer therapy, with no more than three prior lines of therapy.\n4. Diagnosed with cancer cachexia according to the criteria of the 2011 International Consensus on Cancer Cachexia: Definition and Classification, combined with characteristics of the Chinese population, i.e., presenting with one of the following within 6 months (previous weight data must be supported by written documentation approved by the sponsor): involuntary weight loss \\>5%, or weight loss \\>2% when Body Mass Index （BMI） \\\u003C18.5 kg\u002Fm²;\n5. Adequate organ function, meeting relevant laboratory test standards （without transfusion or hematopoietic growth factor support within 14 days prior to testing）:\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: ≤1;\n7. 7\\. Eastern Cooperative Oncology Group Performance Status （ECOG PS）score: ≤2;\n8. Estimated survival ≥4 months;\n9. Fertile eligible patients must use adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last drug administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first drug administration.\n\nExclusion Criteria:\n\n1. Presence of reversible causes leading to decreased food intake;\n2. Patients with dysphagia or poor food digestion and absorption, including gastrointestinal obstruction, active inflammatory bowel disease, or short bowel syndrome;\n3. Patients with cachexia caused by clearly identified other causes, such as severe chronic obstructive pulmonary disease, uncontrolled thyroid disease, vital organ failure, or Acquired Immune Deficiency Syndrome （AIDS）;\n4. Patients receiving tube feeding or parenteral nutrition therapy during the screening period;\n5. Patients who have taken any prescription medications for appetite enhancement or improve weight loss within 28 days or 5 half-lives (whichever is shorter) before the first study drug administration, including but not limited to anamorelin, medroxyprogesterone acetate, dronabinol, medical marijuana, etc.;\n6. Initiation of systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent doses of other similar drugs) or other immunosuppressive therapies within 28 days before the first study drug administration, excluding pretreatment for antitumor therapy;\n7. Patients with a BMI exceeding 30 kg\u002Fm²;\n8. Patients who have undergone major surgery within 4 weeks before the first study drug administration and have not recovered, or are expected to undergo major surgery during the study;\n9. Patients who have received other clinical study medications within 4 weeks or 5 half-lives (whichever is shorter) before the first study drug administration;\n10. Patients with severe infections requiring intravenous antibiotics, antivirals, or antifungals during the screening period;\n11. Patients with difficult-to-control moderate to large amounts of serous cavity effusion, such as pericardial effusion or pleural\u002Fabdominal\u002Fpelvic effusion, within 14 days before the first study drug administration;\n12. Patients with a second primary active malignancy within 2 years before the first study drug administration, excluding locally curable tumors that have undergone radical treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, breast carcinoma in situ);\n13. Patients with active central nervous system metastases (brain metastases, carcinomatous meningitis, and spinal cord metastases), except for those with controlled lesions confirmed by imaging studies within 28 days before the first use of the investigational product;\n14. History of severe cardiovascular disease, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;\n    2. Occurrence of acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade 3 or higher within 6 months before the first study drug administration;\n    3. New York Heart Association functional class ≥III or left ventricular ejection fraction (LVEF) \\\u003C50%;\n15. Patients with severe immune deficiency or a history of organ transplantation;\n16. Patients with recent (within the past year) or current depression or suicidal ideation\u002Ftendencies;\n17. Known allergy to JMT203 or its components;\n18. History of severe allergic reactions or uncontrollable allergic asthma;\n19. Patients deemed unsuitable for participation in this clinical study by the investigator for other reasons.",{"count":104,"type":21},307,[106,107],"PHASE1","PHASE2","A Phase Ia\u002FII, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia",[110,111,28,112,113],"Non Small Cell Lung Cancer","Pancreatic Cancer","Colorectal Cancer Cachexia","Pancreatic Cancer Cachexia","2026-05-19",{"date":116,"type":39},"2026-05-22",{"date":118,"type":39},"2024-05-15",{"date":120,"type":21},"2029-05-15",{"name":122,"class":123},"Shanghai JMT-Bio Inc.","INDUSTRY",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":95},"100639318","phase-1-an-phase-iiia-clinical-study-to-evaluate-the-safetytolerability-pharmacokinetics-and-preliminary-efficacy-of-inb301-injection-in-patients-with-cancer-cachexia-100639318","NCT07584057","An Phase I\u002FIIa Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia","An Open-label, Multicenter Phase I\u002FIIa Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia","Inclusion Criteria:\n\n* Subjects who voluntarily participate in the study and voluntarily sign the informed consent form;\n* Male or female ≥ 18 years of age;\n* Subjects with histologically or cytologically confirmed malignant solid tumors (including pathologically confirmed non-small cell lung cancer, colorectal cancer, pancreatic cancer, esophageal cancer or breast cancer, etc.) who are receiving or have completed anti-cancer treatment and have no significant cancer progression 28 days before the first dose, and in the investigator's expectation are unlikely to change the anti-cancer regimen due to disease progression or do not require any anti-cancer treatment within the first cycle (21 days) of the study;\n* Definitely diagnosed as cancer cachexia according to the 2025 Definition and Classification of Cancer Cachexia: An International Consensus\" combined with clinical practice: one of the following occurs within 6 months (recognized documentation is required for past weight data): involuntary weight loss \\> 5%, or weight loss \\> 2% when BMI \\\u003C 18.5 kg\u002Fm² ;\n* Serum GDF-15 level ≥ 1200 pg\u002FmL within 28 days prior to the first dose (only applicable to Phase I dose expansion and Phase IIa);\n* Adequate organ function, i.e., meeting laboratory criteria:\n\n  * Hematology: absolute neutrophil count ≥ 1.0×10⁹\u002FL, platelets ≥ 75×10⁹\u002FL, hemoglobin ≥ 80 g\u002FL;\n  * Renal: serum creatinine ≤ 1.5 × ULN (if serum creatinine \\> 1.5 × ULN, creatinine clearance calculated with Cockcroft formula ≥ 30 mL\u002Fmin is required);\n  * Hepatic: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN or AST and ALT ≤ 5 × ULN in case of liver metastasis;\n  * Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5;\n* ECOG PS score ≤ 2;\n* Expected survival ≥ 4 months;\n* Eligible subjects of childbearing potential should take adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last dose: for female patients of childbearing age, the blood pregnancy test must be negative within 7 days before the first dose. In addition, subjects should avoid donating sperm\u002Feggs for the time period specified above.\n\nExclusion Criteria:\n\n* Other causes that may lead to reduced food intake or seriously affect digestion and absorption during the screening period, as determined by the investigator, including but not limited to: oral mucositis of NCI CTCAE Grade 3 or above, gastrointestinal disease of NCI CTCAE Grade 3 or above (nausea, vomiting, diarrhea and constipation, etc.), gastrointestinal obstruction, and active inflammatory bowel disease;\n* Radiotherapy is planned as part of the primary anti-cancer treatment regimen (except local radiotherapy for symptom relief);\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis (for subjects with previously treated brain metastases, enrollment may be considered if all of the following criteria are met: the clinical condition has remained stable with no imaging evidence of disease progression within 4 weeks before the first investigational drug treatment, and corticosteroid treatment has not been required within 4 weeks before first dose; asymptomatic subjects with brain metastases (i.e., no neurologic symptoms, no requirement for corticosteroids, and no brain metastatic lesion with a longest diameter \\> 1.5 cm) may be enrolled, provided that regular imaging examination and assessment for brain metastatic lesions are performed);\n* Gavage or parenteral nutrition (total or partial) is received during the screening period;\n* History of other diseases that may cause cachexia within 6 months prior to screening, including but not limited to: severe and above COPD, NYHA class 3-4 heart failure;\n* Human immunodeficiency virus antibody (HIVAb) positive, active hepatitis B (HBsAg and\u002For HBcAb positive and HBV-DNA \\> 500IU\u002FmL or upper limit of normal, whichever is higher), or hepatitis C (anti-HCV positive and HCV-RNA above lower limit of detection). History of hepatitis B vaccination is acceptable;\n* Blood pressure ≥ 140 mmHg (systolic) or ≥ 90 mmHg (diastolic) at screening, measured after at least 5 minutes of rest. If the blood pressure exceeds the standard, the measurement should be repeated twice, and the mean of the three measurements is used to determine whether the subject meets the criterion;\n* Screening 12-lead electrocardiogram (ECG) shows clinically relevant abnormalities that may affect subject safety or interpretation of study results (e.g., baseline QTcF \\> 450 milliseconds or QRS \\> 120 milliseconds). If the baseline uncorrected QT interval is \\> 450 milliseconds, Fridericia's method should be used for correction and QTcF should be used for decision-making. If QTcF \\> 450 milliseconds or QRS \\> 120 milliseconds, the ECG should be repeated twice, and the mean of the three measurements should be used for judgment. Computer-read ECG should be reviewed by experienced physician before excluding a subject;\n* Serious infection for which intravenous antibiotics, antivirals, or antifungals are being administered within 14 days prior to screening or during the screening period;\n* Subjects who have taken any prescription drugs that affect appetite or improve body weight within 28 days before the first dose or 5 half-lives, including but not limited to anamorelin, megestrol acetate, cannabinol, medical marijuana, Chinese patent medicines to improve appetite and traditional Chinese medicine preparations;\n* Subjects who have received systemic glucocorticoids (prednisone \\> 10 mg\u002Fday or equivalent dose of similar product) or other immunosuppressants within 28 days before the first dose, except for anti-cancer treatment or pretreatment of examination;\n* Baseline BMI \\> 26 kg\u002Fm² (for Chinese people)；\n* Previously received anti-GDF-15, GFRAL and iso-mechanism antibodies;\n* Subjects with massive serous effusion within 14 days before screening or during screening, such as pericardial effusion or pleural\u002Fperitoneal effusion;\n* Received major surgery within 28 days before the first dose, or major surgery is expected during the study;\n* History of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  * Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block;\n  * Acute coronary syndrome, congestive heart failure, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first dose of study drug;\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Treated with other clinical investigational drug within 28 days before the first dose or 5 half-lives (whichever is longer);\n* Known allergy to INB301 or its components, or a history of severe allergic reactions or uncontrolled allergic asthma;\n* Other serious physical or mental illness or laboratory abnormality at screening that may increase the risk of study participation or interfere with study results, and other causes that make the subject unsuitable for this clinical study in the opinion of the investigator.",{"count":132,"type":21},146,[106,107],"This is an open-label, multicenter, multiple-dose Phase I\u002FIIa clinical study to assess the safety\u002Ftolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia.\n\nThe indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit\u002Frisk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.",[28],[28],"2026-05-06",{"date":139,"type":39},"2026-05-13",{"date":141,"type":21},"2026-05",{"date":143,"type":21},"2030-03",{"name":145,"class":123},"Yunnan Baiyao Group Co., Ltd.",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100595482","phase-2-an-evaluation-of-ngm120-in-a-randomized-double-blind-placebo-controlled-study-in-participants-with-colorectal-cancer-who-have-cancer-cachexia-100595482","NCT07033026","An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.","A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia","Inclusion Criteria:\n\n1. Documented active diagnosis of colorectal cancer.\n2. Cachexia defined by Fearon criteria of weight loss.\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1. Current active reversible causes of decreased food intake.\n2. Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.\n3. Have cachexia caused by other reasons.",{"count":154,"type":21},136,[107],"A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.",[158,159,28],"Colorectal Cancer","CRC (Colorectal Cancer)",[28,158,161],"CRC","2026-03-30",{"date":164,"type":39},"2026-04-01",{"date":166,"type":39},"2025-06-25",{"date":168,"type":21},"2027-12",{"name":170,"class":123},"NGM Biopharmaceuticals, Inc",28,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":194,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100598533","phase-2-psilocybin-assisted-psychotherapy-in-cancer-patients-with-adjustment-disorder-100598533","NCT07072728","Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70\u002FWeek 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\\u003C 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and\u002For myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90\u002F60 or above 140\u002F90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and\u002For ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\\u003C60 mL\u002Fmin (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg\u002Fm2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","80 Years",{"count":181,"type":21},87,[107],"This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.",[185,186,63,28,187,188,189,190,191,192,193],"Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer of Endometrium","Cancer of Kidney","Cancer of Prostate","Cancer of the Breast","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas",[63,185,195,196,197],"Existential Distress","Psilocybin","Psilocin","2026-03-01",{"date":200,"type":39},"2026-03-03",{"date":202,"type":39},"2025-10-01",{"date":204,"type":21},"2027-07-30",{"name":206,"class":123},"Psyence Australia Pty Ltd",3,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":95},"100612145","a-first-in-human-study-of-fid-022-in-solid-tumor-patients-100612145","NCT07249775","A First-in-Human Study of FID-022 in Solid Tumor Patients","AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically or cytologically confirmed diagnosis of pancreatic exocrine malignancy (e.g.pancreatic ductal adenocarcinoma, acinar cell carcinoma, pancreatic adenosquamous carcinoma, etc.) or clinical features highly suggestive of such malignancy with diagnostic confirmation anticipated during the screening or early study period.\n* Presentation consistent with resectable, borderline resectable, local, or locally advanced, or metastatic disease\n* May or may not have had surgery\n* Treatment plan likely includes systemic therapy for pancreatic cancer\n* ECOG performance status 0-2\n* Able to tolerate oral intake and not currently receiving enteral or parenteral nutrition\n* Able to read and speak English\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding at the time of enrollment\n* Current use of tube feeding (enteral) or total parenteral nutrition\n* Presence of ascites or other findings suggestive of decompensated disease\n* Evidence or history of bowel obstruction or any gastrointestinal condition that may limit food intake\n* Severe or uncontrolled psychiatric illness (e.g., psychosis, dementia) that would interfere with participation\n* Presence of other uncontrolled intercurrent illnesses (e.g., infection, heart failure, liver failure) that may interfere with protocol adherence",{"count":216,"type":21},120,"OBSERVATIONAL","This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.",[111,28],"2026-01-26",{"date":222,"type":39},"2026-01-28",{"date":224,"type":39},"2025-10-08",{"date":226,"type":21},"2026-10",{"name":228,"class":46},"H. Lee Moffitt Cancer Center and Research Institute",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":95},"100367659","flexi-band-resistance-training-versus-ems-exercise-in-patients-with-the-diagnosis-of-malignant-diseases-100367659","NCT04067167","Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases","Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases","FREEDOM","Inclusion Criteria:\n\n* malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation\n* ongoing or planned curative or palliative anti-cancer therapy\n* ECOG-Status 0-2\n\nExclusion Criteria:\n\n* simultaneous participation in other nutritional or exercise intervention Trials\n* bone metastases with high fracture risk\n* cardiovascular disease\n* use of anabolic medications\n* epilepsy\n* severe neurological or rheumatic diseases\n* skin lesions in the area of electrodes\n* energy active metals in body\n* pregnancy\n* acute vein thrombosis",{"count":238,"type":21},100,[24],"The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.",[63,28,242,243],"Inflammation","Muscular Atrophy",[63,245,246,67,247,248,249,250,251],"Cachexia","Muscular strength","Body composition","Muscle mass","Physical exercise","Nutrition","whole-body electromyostimulation","2026-01-15",{"date":254,"type":39},"2026-01-20",{"date":256,"type":39},"2019-05-01",{"date":258,"type":21},"2026-06-30",{"name":94,"class":46},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":267,"sex":55,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":95},"100611198","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-gb18-injection-in-healthy-participants-100611198","NCT07237464","To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Injection in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GB18 Following Single Subcutaneous Injection in Healthy Adult Participants","Inclusion Criteria:\n\n1. Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures, and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n2. Male and female participants aged 18-55 years (inclusive), at the time of signing the ICF.\n3. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI = weight (kg)\u002Fheight 2 (m) 2) of 18.5-26 kg\u002Fm2 (inclusive).\n4. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, Vital signs, 12-lead ECG, and laboratory tests.\n5. Participants (including their partners) who have no plan to become pregnant and voluntarily use effective contraception from screening to 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n2. History of HIV infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb.\n3. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules made of components of monoclonal antibodies.\n4. History of recurrent infections or active infections.\n5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior, or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n6. Smoking more than five cigarettes per day on average, or habitually used nicotine containing products, or unable to refrain from smoking during the trial.\n7. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.\n8. Exposure to live vaccines within 28 days of screening.\n9. Previous administration with an investigational drug within 30 days or marketed or investigational monoclonal antibodies within 3 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n10. History of drug abuse within the past 5 years or use of drugs in the 3 months prior to screening, or a positive urine drug test at screening.\n11. Screening BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.\n12. Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTcF interval \\>450 msec, or QRS interval \\>120 msec). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility.\n13. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:\n\n    * AST or ALT level ≥1.5 × ULN,\n    * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.\n14. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 3 months of Screening. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 360 mL beer, 45 mL of 40% spirit or 150 mL of wine).\n15. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.\n16. Participants who, in the judgment of the investigator, are not suitable for participation in the study.\n17. Skin scar, rash, or ulceration at the injection site (abdomen).\n18. History of vasovagal syncope or needle phobia, and inability to tolerate venous indwelling catheter blood collection.\n19. Participants who plan to donate sperm or oocytes within 6 months after administration of the investigational drug.",true,"55 Years",{"count":270,"type":21},36,[106],"This study is a first-in-human, randomized, double-blind, placebo-controlled, dose-escalation trial in healthy adult participants to evaluate the safety, tolerability, PK, PD, and immunogenicity of GB18.\n\nA total of 36 healthy participants will be enrolled, including 5 dose cohorts (A1-A5) of 50 mg, 100 mg, 200 mg, 400 mg and 600 mg, with 4 participants in Cohort A1, and 8 participants per following cohorts (A2-A5). Participants in each cohort will be randomized to receive GB18 or placebo.\n\nThe arms of this study include:\n\nTo evaluate the safety and tolerability of GB18 following a single subcutaneous (SC) administered dose in healthy adult participants.\n\nTo characterize the serum pharmacokinetics (PK) of GB18 following a single SC administered dose in healthy adult participants.\n\nTo characterize the pharmacodynamics (PD) of a single SC administration of GB18 on circulating GDF15 concentrations in healthy adult participants.\n\nTo evaluate the immunogenicity profile of GB18 in healthy adult participants. To evaluate the effect of GB18 on body weight in healthy adult participants. To preliminary evaluation of the relationship between GB18 serum concentration and QTc interval after a single SC administration in healthy adult participants.",[274,28,275],"Cancer Cachexia (CC)","Cancer Cachexia Syndrome",[30,277,278,279,280,281],"GB18","healthy adult","Phase I","pharmacokinetics","pharmacodynamics","2025-11-16",{"date":284,"type":39},"2025-11-19",{"date":286,"type":39},"2025-10-28",{"date":288,"type":21},"2026-04-20",{"name":290,"class":291},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":267,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":301,"studyType":217,"phases":4,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100576064","structural-characteristics-of-trunk-and-limb-muscles-in-cachectic-colorectal-cancer-patients-100576064","NCT06780423","Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients","CTLm-CCP","Cachectic colorectal cancer patients.\n\nInclusion criteria:\n\n* minimum age of 18 years old\n* unwanted weight loss \\> 5% in the last 6 months OR \\> 2% unwanted weight loss in combination with a BMI \\\u003C 20kg\u002Fm2 OR \\>2% unwanted weight loss in combination with sarcopenia\n* Cachexia staging score (CSS): 5-12\n\nExclusion Criteria:\n\n* Mental of psychological condition\n* Insufficient knowledge of the Dutch language\n* Muscle diseases affecting the spine and lower limbs\n* Bedridden\n\nNon-Cachectic cancer patients.\n\nInclusion criteria:\n\n* minimum age of 18 years old\n* No unwanted weight loss \\> 5% in the last 6 months OR \\> 2% unwanted weight loss in combination with a BMI \\\u003C 20kg\u002Fm2 OR \\>2% unwanted weight loss in combination with sarcopenia\n* Cachexia staging score (CSS): 0-2\n\nExclusion criteria:\n\n* Mental of psychological condition\n* Insufficient knowledge of the Dutch language\n* Muscle diseases affecting the spine and lower limbs\n* Bedridden\n\nHealthy controls.\n\nInclusion criteria:\n\n\\- minimum age of 18 years old\n\nExclusion criteria:\n\n* Mental of psychological condition\n* Insufficient knowledge of the Dutch language\n* Muscle diseases affecting the spine and lower limbs\n* Bedridden",{"count":300,"type":21},60,"2 Days","Until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. Colorectal cancer is the second leading cause of cancer death in developed countries. In advanced colorectal cancer, 60% of these patients develop cachexia. The presence of cachexia plays an important role in the high mortality rate of cancer. Cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass.\n\nThe aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. Skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls.\n\n10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. It is an observational study, so measurements will be taken at one time point. Interventions\u002Fmeasurements:\n\n* muscle biopsies\n* blood samples\n* 3D freehand ultrasound\n* Short physical performance battery test\n* handgrip strength\n* questionnaires (activity pattern, quality of life)",[158,28],[305,306,307,308,309],"colorectal cancer","cachexia","skeletal muscle","skeletal muscle fibers","capillarization","2025-09-08",{"date":312,"type":39},"2025-09-09",{"date":314,"type":39},"2022-01-23",{"date":316,"type":21},"2025-09-10",{"name":318,"class":46},"Hasselt University",2,{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":179,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":95},"100585122","phase-1-a-phase-i-study-to-evaluate-gfs202a-in-advanced-solid-tumor-patients-with-pre-cachexia-or-cachexia-100585122","NCT06898255","A Phase I Study to Evaluate GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia","An Open-label, Multi-center, Phase I Study to Evaluate the Safety\u002FTolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form.\n2. Men or women between the ages of 18 and 80 years at the time of written informed consent.\n3. Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI \\\u003C 21 kg\u002Fm2 within 6 months before the first study dose.\n4. Persistent concomitant appetite\u002Feating problems related to cancer.\n5. It has adequate organ function.\n6. The ECOG PS score was 0-2.\n7. The investigator judged the expected survival time to be ≥ 3 months.\n\nExclusion Criteria:\n\n1. With active brain metastases.\n2. With other active diseases that lead to reduced food intake or seriously affect digestion and absorption\n3. Baseline BMI \\> 28 kg\u002Fm2.\n4. With infectious diseases.\n5. With clinically significant cardiovascular disease.\n6. With uncontrolled metabolic diseases.\n7. With known clinically significant allergic reactions to antibodies and excipients.\n8. With history of drug or alcohol abuse.\n9. Pregnant or lactating female subjects or women planning to become pregnant during the study.\n10. With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time\u002Fmonth).\n11. Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.",{"count":270,"type":21},[106],"An open-label, multi-center, phase I study to evaluate the safety\u002Ftolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety\u002Ftolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.\n\nEnroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) \u002Fbiomarker samples will be collected.",[28],[306,332,333,334],"cancer","GDF-15","IL-6","2025-06-03",{"date":337,"type":39},"2025-06-05",{"date":339,"type":39},"2025-04-24",{"date":341,"type":21},"2026-07-06",{"name":343,"class":123},"Genfleet Therapeutics (Shanghai) Inc."]