[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503234":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":52,"collaborators":19,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":19,"enrollmentInfo":63,"targetDuration":19,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":19,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"High Fiber diet","EXPERIMENTAL","During the first 12 weeks of immune checkpoint inhibitor therapy, patients will receive weekly boxes containing 30 different plants (vegetables, fruits, nuts, grains) according to seasonal availability following the Flemish Superior Health Council guidelines. Recipes will be added to inspire processing of the box. Boxes will be ordered at an online supermarket, who will deliver the boxes at patients' homes. Weekly follow-up will ensure a minimum daily intake of 20 g of fiber, progressively increasing over the first 4 weeks.",[13],"Other: Food box containing 30 different plants",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Food box containing 30 different plants","Food boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Sandrine Aspeslagh, MD PhD","Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Marthe Verhaert, MD","CONTACT","+3224749480","marthe.verhaert@uzbrussel.be",{"name":22,"role":28,"phone":19,"phoneExt":19,"email":32},"sandrine.aspeslagh@uzbrussel.be",[34],{"facility":35,"status":36,"city":37,"state":19,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"UZ Brussel","RECRUITING","Jette","1090","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.33419,50.87309,{"lat":45,"lon":44},[48,50],{"name":49,"role":28,"phone":19,"phoneExt":19,"email":32},"Sandrine Aspeslagh, MD, PhD",{"name":27,"role":28,"phone":51,"phoneExt":19,"email":30},"+3224779480",{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100503234","food-intervention-to-reduce-immunotherapy-toxicity-100503234",false,"NCT05832606","Food Intervention to Reduce Immunotherapy ToXicity","FORX01","Inclusion Criteria:\n\n* solid tumor starting anti-programmed cell death protein 1 (anti-PD1) and\u002For anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA4) antibodies as part of standard of care.\n* able to sign informed consent.\n\nExclusion Criteria:\n\n* no oral intake possible.\n* probiotic use and unwillingness to stop during the trial.\n* combination therapy with chemotherapy or targeted agents.","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"NA","The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.",[71,72],"Immune-related Adverse Event","Dietary Habits","2025-03-21",{"date":75,"type":76},"2025-03-26","ACTUAL",{"date":78,"type":76},"2024-01-01",{"date":80,"type":65},"2026-12-31",{"name":5,"class":6},1]