[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-cachexia-cc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-cachexia-cc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100611198","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-gb18-injection-in-healthy-participants-100611198",false,"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,"ALL","18 Years","55 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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.",[28,29,30],"Cancer Cachexia (CC)","Cancer Cachexia","Cancer Cachexia Syndrome",[32,33,34,35,36,37],"Cancer cachexia","GB18","healthy adult","Phase I","pharmacokinetics","pharmacodynamics","RECRUITING","2025-11-16",{"date":41,"type":42},"2025-11-19","ACTUAL",{"date":44,"type":42},"2025-10-28",{"date":46,"type":22},"2026-04-20",{"name":48,"class":49},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":50},"100572778","effects-of-aerobic-and-resistance-exercise-training-in-individuals-with-cancer-cachexia-100572778","NCT06737692","Effects of Aerobic and Resistance Exercise Training in Individuals with Cancer Cachexia","Investigation of the Effects of Aerobic and Resistance Exercise Training in Individuals with Gastrointestinal Cancer and Cachexia: Randomized Controlled Single-Blind Study","Exercise","Inclusion Criteria:\n\n* Stage III-IV gastrointestinal cancer diagnosis\n* Age 18-65\n* Receiving systemic treatment (chemotherapy and\u002For targeted therapy and\u002For immunotherapy), at least 6 weeks after surgery,\n* Karnofsky performance score 80 and above,\n* Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (\\>5% weight loss in the last 6 months or \\>2% weight loss in patients with BMI less than 20 kg\u002Fm2 or \\>2% weight loss in sarcopenic individuals)\n\nExclusion Criteria:\n\n* Musculoskeletal disorder\n* Neurological disorder\n* Severely impaired hematological capacity\n* History of cardiac disease\n* Uncontrolled hypertension\n* Severe renal insufficiency\n* Advanced osteoporosis\n* Decreased ability to stand or walk","65 Years",{"count":61,"type":22},40,[63],"NA","This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.\n\nA total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.\n\nBefore the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:\n\nBody Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.\n\nThe exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.\n\nThe intensity will be progressively adjusted based on the individual's perceived exertion.",[28],[67,68,69,70,71],"exercise","cancer","cachexia","aerobic","resistance","NOT_YET_RECRUITING","2024-12-16",{"date":75,"type":42},"2024-12-17",{"date":77,"type":22},"2025-01-01",{"date":79,"type":22},"2025-12-31",{"name":81,"class":82},"Dokuz Eylul University","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":50},"100565660","assessment-and-modulation-of-energy-balance-in-cachectic-patients-using-adapted-physical-activity-100565660","NCT06645067","Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity","Cachectic Cancers and Adapted Physical Activity Assessment and Modulation of Energy Balance in Cachectic Patients Using Adapted Physical Activity","EMC2APA","Inclusion Criteria:\n\n* Be at least 18 years old.\n* Have understood the objectives of the study.\n* Have read and signed the consent form.\n* Be affiliated with a social security system.\n* Currently undergoing cancer treatment.\n\nExclusion Criteria:\n\n* Une fatigue extrême\n* Une anémie symptomatique (hémoglobine ≤ 8 g\u002Fdl)\n* Un syndrome infectieux sévère en cours d'évolution\n* Une décompensation de pathologie cardio-pulmonaire\n* La présence de lésions osseuses lytiques du rachis ou des os longs (la contre-indication concerne la mobilisation du membre atteint)\n* Une intolérance au port du masque de l'appareil K5 (Cosmed)","80 Years",{"count":93,"type":22},10,"OBSERVATIONAL","1. OBJECTIVE OF THE STUDY The study consists of evaluating resting energy expenditure (REE) and that induced by adapted physical activity (APA) in cachectic patients, compared with those predicted by equations and those of non-cachectic cancer patients. We will also seek to identify potential compensations in the level of Physical Activity (PA) and dietary intake during one week of the PA programme.\n2. CONDUCT OF THE STUDY Taking part in this study will in no way affect your treatment at SPORMED; you will undergo the same assessments and carry out the PAA programme in the same way. As a reminder, your treatment at SPORMED consists of an initial assessment session, a 12-week ABS programme and a final assessment session.\n\nIf you take part in the EMC2APA study, we will ask you to measure your gas exchange at rest (60 minutes) and during the aerobic part of one of your physical activity sessions. You will perform the effort traditionally targeted during the sessions (constant moderate intensity (60% of your Reserve Heart Rate, equivalent to a perception of the difficulty of the effort of 5-6\u002F10) while your gas exchanges will be measured using a portable, non-invasive measuring device (K5, COSMED®). You will also be fitted with an accelerometric wristwatch.\n\nIn addition to the gas exchange measurements that will take place in the SPORMED structure, we will ask you to fill in a logbook tracking your daily physical activity and your daily food intake. You will also be asked to wear an accelerometer in a belt attached to your hip for 7 days.\n\nParticipation in this study is voluntary. There are no restrictions during the protocol.",[28,57,97],"Energy Regulation",[29,57,99,100,101,102],"Endurance","Energy Expenditure","Food Intake","Physical activity","2024-10-15",{"date":105,"type":42},"2024-10-16",{"date":107,"type":22},"2025-02",{"date":109,"type":22},"2025-12",{"name":111,"class":82},"University of Rennes 2"]