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

Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy of Non-Pharmacological Interventions on Neurotoxicity Associated With CAR-T Therapy in Hematologic Patients

This test will try whether a structured exercise program alone or combined with nutrition advice can lower the risk or severity of neurotoxicity after CAR‑T therapy in adults (18–80) with hematologic cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto de Investigacion Sanitaria INCLIVA (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 2 sites (Valencia, Valencia and 1 other locations)
• Trial ID: NCT07173166 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with a hematologic malignancy who are scheduled to receive CAR‑T cell therapy and who can participate in exercise and follow nutritional guidance are ideal candidates.

Not a fit: Patients with language barriers, significant physical or cognitive impairments, pre‑existing neurological or psychiatric conditions, concurrent neurotoxic medications, or a history of abusive neurotoxic substance use may not be able to participate or benefit.

Why it matters

Potential benefit: If successful, these non‑drug approaches could reduce the incidence or severity of CAR‑T–related neurotoxicity and speed recovery, improving patient function and quality of life.

How similar studies have performed: Exercise and nutrition programs have shown benefits for some chemotherapy‑related side effects in other cancer populations, but applying these interventions specifically to CAR‑T–related neurotoxicity is novel and not yet well tested.

Eligibility criteria

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 this trial is running

Valencia, Valencia and 1 other locations

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

Conditions Hematologic Cancer; CAR-T therapy; Neurotoxicity; Nutrition; Physical activity