CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：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 · 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. · At baseline and from the infusion of treatment until 15 days after CAR-T therapy.
次要终点：Functional independence as assessed by the Lawton and Brody Instrumental Activities of Daily Living (IADL) scale；Physical activity level as assessed by the International Physical Activity Questionnaire (IPAQ)；Nutritional status as assessed by the Patient-Generated Subjective Global Assessment (PG-SGA)；Quality of life as assessed by the Short Form 12 (SF-12)；Adherence to interventions

• Physical activity · 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.
• Physical activity and nutrition · 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.
• Control · NO_INTERVENTION · The control group will serve to establish a baseline for identifying clinical, demographic, and response patterns of the studied variables. All procedures and interventions will be conducted in accordance with the center's standard clinical practice.

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.