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

Last updated: March 7, 2026
Sponsor: Instituto de Investigacion Sanitaria INCLIVA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Cancer

Hematologic Neoplasms

Treatment

Physical activity and nutrition

Physical activity

Clinical Study ID

NCT07173166
2025/185
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Presence of language barriers or physical and/or cognitive impairments that hinderthe understanding of the interventions or prevent proper completion of theassessment tools used in the study.

  • Pre-existing neurological or psychiatric comorbidities that may interfere with theevaluation of neurotoxic effects of the hematologic treatment.

  • Concomitant treatment with additional neurotoxic drugs not related to the studyprotocol.

  • History of abusive consumption of neurotoxic substances.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Physical activity and nutrition
Phase:
Study Start date:
September 30, 2025
Estimated Completion Date:
September 30, 2028

Study Description

A parallel-group, multicenter and randomized controlled clinical trial will be conducted from July 2025 to July 2027. The study will evaluate the effectiveness of two non-pharmacological interventions in reducing neurotoxicity associated with CAR-T cell therapy in adult patients with hematologic cancer.

A total of 100 patients will be enrolled and randomly assigned into three groups using stratified randomization performed by an individual external to the research team.

The intervention will begin at least one month prior to CAR-T cell infusion. Participants will be followed weekly before, during, and for four weeks after therapy. Interventions and evaluations will be carried out in the same hospital where the patient receives treatment, and always by the same multidisciplinary team (hematologists, nurses, nutritionists, physiotherapists).

Primary and secondary outcomes will be assessed at baseline (prior to intervention), during treatment, and post-treatment follow-up. Written informed consent will be obtained from all participants before enrollment.

Connect with a study center

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia 46010
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia 46026
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia 2509954, Valencia 2593113 46010
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Site Not Available

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