[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651435":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":19,"enrollmentInfo":71,"targetDuration":19,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":42,"whyStopped":19,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise and Nutritional Intervention","EXPERIMENTAL","Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, together with a six-month structured resistance exercise program performed three times per week under the supervision of trained exercise professionals and individualized nutritional support.",[13,14],"Behavioral: Structured Resistance Exercise","Behavioral: Individualized Nutritional Support",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Oncology Care","NO_INTERVENTION","Participants will receive standard oncology care, including treatment with immune checkpoint inhibitors, without the additional structured exercise program or individualized nutritional intervention.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"BEHAVIORAL","Structured Resistance Exercise","A 24-week supervised and progressive whole-body resistance exercise program performed three times per week under the guidance of trained exercise professionals. Each session will last approximately 60 minutes and will include resistance exercises targeting the major muscle groups of the upper and lower body. Exercise intensity will progressively increase from approximately 60% to 70% of one-repetition maximum. A deload week at approximately 60% of one-repetition maximum will be scheduled every fourth week. Training load will be adjusted using repeated one-repetition maximum assessments and the Borg Rating of Perceived Exertion Scale. Exercise will not be performed on the day before study assessments to avoid acute effects on the measurements.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Individualized Nutritional Support","Individualized nutritional assessment and counseling provided by a clinical dietitian in cooperation with a physician specializing in clinical nutrition. Energy requirements will be determined using indirect calorimetry. The nutritional strategy will target a daily protein intake of 1.5 to 2 g\u002Fkg of body weight and a daily fiber intake of 30 to 40 g. Participants will receive 30 g of whey protein to be consumed within one hour after each exercise session. Oral nutritional supplements and other appropriate nutritional therapy will be prescribed when clinically indicated, including in participants with inadequate intake, malnutrition, cachexia, or sarcopenia.",[9],[31],{"name":32,"affiliation":5,"role":33},"Nada Rotovnik Kozjek","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Nada Rotovnik Kozjek, MD, PhD","CONTACT","+38641 612 541","NKozjek@onko-i.si",[41],{"facility":5,"status":42,"city":43,"state":19,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":48,"coordinates":49},"Point",[50,51],14.50513,46.05108,{"lat":51,"lon":50},[54,55],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},{"name":32,"role":33,"phone":19,"phoneExt":19,"email":19},{"type":57,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[59],{"name":60,"class":6},"Science and Research Centre Koper","100651435","exercise-and-nutritional-intervention-in-patients-with-melanoma-receiving-immunotherapy-100651435",false,"NCT07761871","Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy","Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy","MEL-FIT-IO","Inclusion Criteria:\n\n* Age 18 years or older.\n* Confirmed diagnosis of malignant melanoma, stage II, III, or IV.\n* Planned first-line or adjuvant treatment with immune checkpoint inhibitors.\n* Life expectancy greater than 6 months.\n* Sufficient knowledge of the Slovenian language.\n* Ability to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n* Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors.\n* Symptomatic brain metastases.\n* Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants.\n* Neurological diseases affecting the skeletal muscular system, such as muscular dystrophy.\n* Any condition that, in the investigator's judgment, prevents participation or the safe performance of study assessments.\n* Participation in another study that includes structured physical exercise as part of its protocol.","ALL","18 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","The purpose of this randomized study is to evaluate whether a six-month program of structured resistance exercise combined with individualized nutritional support can preserve or improve skeletal muscle mass and muscle quality in adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors.\n\nParticipants will be randomly assigned either to the exercise and nutritional intervention in addition to standard oncology care or to standard oncology care alone. The study aims to obtain complete measurements from at least 40 participants.\n\nAssessments will be performed at baseline, after 3 months, and after 6 months. They will include magnetic resonance imaging of the thigh, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, indirect calorimetry, clinical data, and patient-reported outcomes. The study will compare changes in skeletal muscle mass and volume, fatty infiltration of skeletal muscle, sarcopenia, body composition, resting energy expenditure, quality of life, fatigue, treatment tolerance, treatment delays, and early treatment discontinuation between the two groups.\n\nTreatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.",[79],"Melanoma",[81,82,83,84,85,86],"Immune Checkpoint Inhibitors","Resistance Exercise","Nutritional Intervention","Skeletal Muscle Mass","Muscle Quality","Sarcopenia","2026-08-10",{"date":89,"type":90},"2026-08-12","ACTUAL",{"date":92,"type":73},"2026-08",{"date":94,"type":73},"2029-06",{"name":5,"class":6},1]