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

Condition(s) studied

Investigational drug(s) / intervention(s)

Physical activity: Patients assigned to intervention group A will follow a supervised programme of physical activity and exercise at home and during hospitalisation. All patients will follow the same exercise programme, which will be adapted to a basic, intermediate and advanced level to suit the patients' physical condition. The loads, intensity and number of sets will be adapted to each level. Aerobic exercise will consist of walking and/or cycling at an intensity of between two and five on the Borg perceived exertion (RPE) scale. Resistance exercise will consist of one session focusing on the trunk and upper limbs, and another on the lower limbs. Both sessions will include seven exercises, performed at an intensity of between three and four on the Borg RPE scale.

Physical activity and nutrition: The intervention integrates a structured physical activity programme with individualized nutritional recommendations based on the Mediterranean diet. Macronutrient distribution was 50-55% carbohydrates, 30-35% fats, and 10-15% proteins. The protocol emphasized the intake of vegetables (≥2 servings/day, 200 g each), fruits (1-2 servings/day, 150 g each), legumes (≥3 servings/week, 150 g cooked), whole grains (1-2 servings/meal, 40-60 g), and low-fat dairy products (1-2 servings/day; 200 ml milk or 125 g yoghurt). Lean meats were prescribed at 3-4 servings/week (100-125 g each), fish and seafood at 4 servings/week (150 g each), nuts at 3-7 servings/week (30 g each), and olive oil as the principal fat source (≤4 tbsp/day). Micronutrients and bioactive compounds from these foods, including antioxidants, polyphenols, and essential fatty acids, were recognized as pivotal for modulating protective mechanisms and mitigating toxicological effects.

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

Primary outcome measure(s)

• Incidence and severity of neurotoxicity as assessed by American Society for Transplantation and Cellular Therapy (ASCT) Immune Effector Cell-Associated Encephalopathy (ICE) consensus grading system — At baseline and from the infusion of treatment until 15 days after CAR-T therapy.
  Patients will undergo a standardised neurological evaluation. The American Society for Transplantation and Cellular Therapy (ASCT) classifies immune effector cell-associated encephalopathy (ICE), which grades the associated neurotoxicity from 1 to 4. It consists of five domains: ICE score, decreased level of consciousness, convulsions, motor findings and elevated intracranial pressure or cerebral oedema. The ICE score evaluates five cognitive domains (orientation, object naming, following instructions, writing and attention) with a maximum score of 10 points.

Trial sites (2)

Other trials for the same condition