[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606254":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":64,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Instituto de Investigacion Sanitaria INCLIVA","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Physical activity","EXPERIMENTAL","Patients assigned to intervention group A will follow a supervised programme of physical activity and exercise at home and during their hospital stay. These recommendations are designed and supervised by a physiotherapist. The programme will include three weekly aerobic exercise sessions and two resistance exercise sessions, as recommended in the literature. Each session will last approximately 35 minutes and will include a warm-up, training and cool-down.\n\nAll patients will follow the same exercise programme, which will be adapted to a basic, intermediate and advanced level to adapt to the patients' physical condition. The loads, intensity and number of sets will be adapted for each level.\n\nThe programme is scheduled to commence one month prior to the initiation of CAR-T therapy. It is recommended that patients adhere to the professional's guidelines for a period of at least one month following treatment.",[13],"Other: Physical activity",{"label":15,"type":10,"description":16,"interventionNames":17},"Physical activity and nutrition","The intervention combines a structured physical activity programme with individualised nutritional recommendations based on the Mediterranean diet. These recommendations are designed and supervised by a nutritionist and a physiotherapist. The macronutrient distribution followed standard guidelines (50-55% carbohydrates, 30-35% fats, 10-15% proteins), emphasising vegetables, fruits, legumes, cereals, dairy, lean meats, fish, nuts, and olive oil. Each food group contributes bioactive compounds with anti-inflammatory and antioxidant properties, including lycopene, quercetin, anthocyanins, genistein, ferulic acid, SCFAs, omega-3 fatty acids and polyphenols. These have been shown to mitigate oxidative stress, inflammation and toxicological effects, thereby supporting cardio.\n\nThe programme is scheduled to commence one month prior to the initiation of CAR-T therapy. It is recommended that patients adhere to the professional's guidelines for a period of at least one month following treatment.",[13,18],"Other: Physical activity and nutrition",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","NO_INTERVENTION","The control group will serve to establish a baseline for identifying clinical, demographic, and response patterns of the studied variables. All procedures and interventions will be conducted in accordance with the center's standard clinical practice.",null,[25,28],{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":23},"Patients assigned to intervention group A will follow a supervised programme of physical activity and exercise at home and during hospitalisation. All patients will follow the same exercise programme, which will be adapted to a basic, intermediate and advanced level to suit the patients' physical condition. The loads, intensity and number of sets will be adapted to each level.\n\nAerobic exercise will consist of walking and\u002For cycling at an intensity of between two and five on the Borg perceived exertion (RPE) scale. Resistance exercise will consist of one session focusing on the trunk and upper limbs, and another on the lower limbs. Both sessions will include seven exercises, performed at an intensity of between three and four on the Borg RPE scale.",[9,15],{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":23},"The intervention integrates a structured physical activity programme with individualized nutritional recommendations based on the Mediterranean diet. Macronutrient distribution was 50-55% carbohydrates, 30-35% fats, and 10-15% proteins. The protocol emphasized the intake of vegetables (≥2 servings\u002Fday, 200 g each), fruits (1-2 servings\u002Fday, 150 g each), legumes (≥3 servings\u002Fweek, 150 g cooked), whole grains (1-2 servings\u002Fmeal, 40-60 g), and low-fat dairy products (1-2 servings\u002Fday; 200 ml milk or 125 g yoghurt). Lean meats were prescribed at 3-4 servings\u002Fweek (100-125 g each), fish and seafood at 4 servings\u002Fweek (150 g each), nuts at 3-7 servings\u002Fweek (30 g each), and olive oil as the principal fat source (≤4 tbsp\u002Fday). Micronutrients and bioactive compounds from these foods, including antioxidants, polyphenols, and essential fatty acids, were recognized as pivotal for modulating protective mechanisms and mitigating toxicological effects.",[15],[32],{"name":33,"affiliation":5,"role":34},"Marina Hernandez Aliaga, RN, MSc, PhD(c)","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":23,"email":39},"CONTACT","+34 655707385","marinaheral27@gmail.com",[41,57],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital Clínico Universitario de Valencia","RECRUITING","Valencia","46010","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],-0.37966,39.47391,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":23,"email":39},"Marina Hernández Aliaga",{"facility":58,"status":59,"city":44,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":23},"Hospital Universitario y Politécnico La Fe","ACTIVE_NOT_RECRUITING","46026",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},{"type":34,"investigatorFullName":56,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Principal Investigator","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":78,"type":79},100,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Hematologic Cancer",[87,88,89,9],"CAR-T therapy","Neurotoxicity","Nutrition","2026-03-07",{"date":92,"type":93},"2026-03-10","ACTUAL",{"date":95,"type":93},"2025-09-30",{"date":97,"type":79},"2028-09",{"name":5,"class":6},2]