[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto de Investigacion Sanitaria INCLIVA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100606254","non-pharmacological-interventions-for-neurotoxicity-in-hematologic-patients-receiving-car-t-therapy-100606254",false,"NCT07173166","Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy","Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy of Non-Pharmacological Interventions on Neurotoxicity Associated With CAR-T Therapy in Hematologic Patients","CARE-T","Inclusion Criteria:\n\n* Male and female patients, aged 18 to 80 years.\n* Diagnosed with a hematological condition.\n* Initiating antineoplastic treatment with CAR-T cell therapy.\n\nExclusion Criteria:\n\n* Presence of language barriers or physical and\u002For cognitive impairments that hinder the understanding of the interventions or prevent proper completion of the assessment tools used in the study.\n* Pre-existing neurological or psychiatric comorbidities that may interfere with the evaluation of neurotoxic effects of the hematologic treatment.\n* Concomitant treatment with additional neurotoxic drugs not related to the study protocol.\n* History of abusive consumption of neurotoxic substances.","ALL","18 Years","80 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if two non-pharmacological strategies can help reduce neurotoxicity caused by CAR-T cell therapy in adult patients with hematologic cancer, both sexes, aged 18 to 80 years. The strategies are:\n\n* A structured physical activity program.\n* A combination of physical activity and nutritional recommendations.\n\nThe main questions it aims to answer are:\n\n* Does physical activity help lower the risk or severity of neurotoxicity after CAR-T therapy?\n* Does combining physical activity with nutritional recommendations provide greater protection against neurotoxicity than physical activity alone?\n\nResearchers will compare two intervention groups with a control group (no intervention) to see which approach is most effective in reducing neurotoxicity and improving recovery.\n\nParticipants will be randomly assigned to one of three groups using stratified randomization to ensure balanced clinical and demographic characteristics:\n\n* Group A: Structured physical activity program.\n* Group B: Structured physical activity program combined wuth nutritional recommendations.\n* Group C: No intervention; used to establish baseline patterns.\n\nParticipants will be evaluated periodically by study professionals. Comprehensive records of symptoms, health measurements, and relevant lifestyle data will be maintained throughout the study.",[28],"Hematologic Cancer",[30,31,32,33],"CAR-T therapy","Neurotoxicity","Nutrition","Physical activity","RECRUITING","2026-03-07",{"date":37,"type":38},"2026-03-10","ACTUAL",{"date":40,"type":38},"2025-09-30",{"date":42,"type":22},"2028-09",{"name":44,"class":45},"Instituto de Investigacion Sanitaria INCLIVA","OTHER",2,""]