Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT07173166
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy
Sponsor:
Instituto de Investigacion Sanitaria INCLIVA
Organization:
Study Overview
Official Title:
Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy of Non-Pharmacological Interventions on Neurotoxicity Associated With CAR-T Therapy in Hematologic Patients
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-T
Brief 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.
* 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: