Recruiting

CARE-TNon-Pharmacological Interventions for Neurotoxicity in CAR-T Therapy Patients

What is being tested

Physical activity

+ Physical activity and nutrition

Other

Who is being recruted

Behavior+8

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

From 18 to 80 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorInstituto de Investigacion Sanitaria INCLIVA

Study ContactMarina Hernandez Aliaga, RN, MSc, PhD(c)

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 6, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding better ways to manage a side effect known as neurotoxicity, which can occur in patients receiving CAR-T cell therapy for blood cancers. Neurotoxicity affects the nervous system and can lead to complications like confusion or seizures. The trial aims to test the effectiveness of two non-drug treatments in reducing these unwanted effects. The study targets adult patients with hematologic cancers, and the results could potentially improve the quality of life for these patients by offering new strategies to manage symptoms without relying on additional medications. Participants in this trial will be divided into three groups through a random process. The intervention will start at least a month before the patients receive their CAR-T cell therapy. Throughout the study, participants will be monitored weekly by a team of healthcare professionals including hematologists, nurses, nutritionists, and physiotherapists. The study will measure outcomes at different stages: before the intervention begins, during the treatment, and after the treatment is completed. This careful monitoring helps to evaluate how well the non-drug treatments are working in reducing neurotoxicity. All participants will provide written consent before joining the study, ensuring they are fully informed about the process and any potential risks or benefits involved.

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

NCT07173166

Principal SponsorInstituto de Investigacion Sanitaria INCLIVA

Study ContactMarina Hernandez Aliaga, RN, MSc, PhD(c)

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorHematologic DiseasesHemic and Lymphatic DiseasesMotor ActivityNeoplasmsNeoplasms by SiteNervous System DiseasesPoisoningHematologic NeoplasmsNeurotoxicity SyndromesChemically-Induced Disorders

Criteria

3 inclusion criteria required to participate

Male and female patients, aged 18 to 80 years.

Diagnosed with a hematological condition.

Initiating antineoplastic treatment with CAR-T cell therapy.

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients assigned to intervention group A will follow a supervised programme of physical activity and exercise at home and during their hospital stay. These recommendations are designed and supervised by a physiotherapist. The programme will include three weekly aerobic exercise sessions and two resistance exercise sessions, as recommended in the literature. Each session will last approximately 35 minutes and will include a warm-up, training and cool-down. All patients will follow the same exercise programme, which will be adapted to a basic, intermediate and advanced level to adapt to the patients' physical condition. The loads, intensity and number of sets will be adapted for each level. The programme is scheduled to commence one month prior to the initiation of CAR-T therapy. It is recommended that patients adhere to the professional's guidelines for a period of at least one month following treatment.

Group II

Experimental

The intervention combines a structured physical activity programme with individualised nutritional recommendations based on the Mediterranean diet. These recommendations are designed and supervised by a nutritionist and a physiotherapist. The macronutrient distribution followed standard guidelines (50-55% carbohydrates, 30-35% fats, 10-15% proteins), emphasising vegetables, fruits, legumes, cereals, dairy, lean meats, fish, nuts, and olive oil. Each food group contributes bioactive compounds with anti-inflammatory and antioxidant properties, including lycopene, quercetin, anthocyanins, genistein, ferulic acid, SCFAs, omega-3 fatty acids and polyphenols. These have been shown to mitigate oxidative stress, inflammation and toxicological effects, thereby supporting cardio. The programme is scheduled to commence one month prior to the initiation of CAR-T therapy. It is recommended that patients adhere to the professional's guidelines for a period of at least one month following treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Hospital Clínico Universitario de Valencia

Valencia, SpainOpen Hospital Clínico Universitario de Valencia in Google Maps

Suspended

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Recruiting

2 Study Centers