Actively Recruiting
Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy
Led by Instituto de Investigacion Sanitaria INCLIVA · Updated on 2026-03-10
100
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients, aged 18 to 80 years.
- Diagnosed with a hematological condition.
- Starting antineoplastic treatment with CAR-T cell therapy.
You will not qualify if you...
- Language barriers or physical/cognitive impairments preventing understanding or completion of study assessments.
- Existing neurological or psychiatric conditions that could interfere with neurotoxicity evaluation.
- Use of other neurotoxic drugs not related to the study.
- History of abusive use of neurotoxic substances.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
2
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Active, Not Recruiting
Research Team
M
Marina Hernandez Aliaga, RN, MSc, PhD(c)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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