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

Recruiting now · Not applicable

Conditions studied: Hematologic Cancer

In brief

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.

Key facts

Study ID

NCT07173166

Run by

Instituto de Investigacion Sanitaria INCLIVA

People needed

338

Starts

2025-09-30

Expected to finish

2028-09-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients, aged 18 to 80 years.
• Diagnosed with a hematological condition.
• Initiating antineoplastic treatment with CAR-T cell therapy.

You may not qualify if…

• 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.

Where it is running

• Hospital Clínico Universitario de Valencia — Valencia, Valencia, Spain (enrolling)
• Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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