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

RECRUITINGN/ASponsored by Instituto de Investigacion Sanitaria INCLIVA
Actively Recruiting
PhaseN/A
SponsorInstituto de Investigacion Sanitaria INCLIVA
Started2025-07-06
Est. completion2027-07
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

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 randomization to ensure balanced clinical and demographic characteristics: * Group A: Structured physical activity program. * Group B: Structured physical activity program combined wuth nutritional recommendations. * Group C: No intervention; used to establish baseline patterns. Participants will be evaluated periodically by study professionals. Comprehensive records of symptoms, health measurements, and relevant lifestyle data will be maintained throughout the study.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions2

CancerHematologic Cancer

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