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Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy

RecruitingNAAges 18 Years - 80 YearsAllInstituto de Investigacion Sanitaria INCLIVA
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In plain words

What the trial is, and whether it could suit you

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: * A structured physical activity program. * A combination of physical activity and nutritional recommendations. The main questions it aims to answer are: * Does physical activity help lower the risk or severity of neurotoxicity after CAR-T therapy? * Does combining physical activity with nutritional recommendations provide greater protection against neurotoxicity than physical activity alone? Researchers will compare two intervention groups with a control group (no intervention) to see which approach is most effective in reducing neurotoxicity and improving recovery. Participants will be randomly assigned to one of three groups using stratified rando

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and female patients, aged 18 to 80 years. * Diagnosed with a hematological condition. * Initiating antineoplastic treatment with CAR-T cell therapy. Exclusion Criteria: * Presence of language barriers or physical and/or cognitive impairments that hinder the understanding of the interventions or prevent proper completion of the assessment tools used in the study. * Pre-existing neurological or psychiatric comorbidities that may interfere with the evaluation of neurotoxic effects of the hematologic treatment. * Concomitant treatment with additional neurotoxic drugs not related to the study protocol. * History of abusive consumption of neurotoxic substances.
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What it tests

  • Physical activity
  • Physical activity and nutrition
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Where

2 sites
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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