Using exercise and nutrition to reduce CAR‑T neurotoxicity in adults with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, parallel‑group trial in Valencia that will enroll 100 adults receiving CAR‑T therapy and assign them to structured physical activity, physical activity plus nutritional recommendations, or no intervention. Interventions begin at least one month before CAR‑T infusion and participants are followed weekly before, during, and for four weeks after treatment. Stratified randomization performed by an external individual will ensure balanced clinical and demographic characteristics across the three groups, and the same multidisciplinary team at each treating hospital will deliver the interventions and assessments. Neurotoxicity and recovery outcomes will be measured at baseline, during treatment, and in the post‑treatment follow‑up period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínico Universitario de Valencia
  Valencia, Valencia, Spain Recruiting
• Hospital Universitario y Politécnico La Fe
  Valencia, Valencia, Spain Recruiting

Study contacts

• Principal investigator: Marina Hernandez Aliaga, RN, MSc, PhD(c) — Instituto de Investigacion Sanitaria INCLIVA
• Study coordinator: Marina Hernandez Aliaga, RN, MSc, PhD(c)
• Email: marinaheral27@gmail.com
• Phone: +34 655707385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.