Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-28 @ 8:27 PM
Study NCT ID:
NCT06312969
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technological Gaming in Cancer Survivors (WINNERS)
Sponsor:
Antonio Pérez Martínez
Organization:
Study Overview
Official Title:
Cognitive Training Through Technological Gaming To Ameliorate Cognitive Effects Related To Childhood Cancer Treatment (WINNERS)
Status:
RECRUITING
Status Verified Date:
2024-03
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:
WINNERS
Brief Summary:
HYPOTHESIS
1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.
VARIABLES
1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
2. Statistically significant changes in neuroimaging tests.
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.
STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.
POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).
1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.
VARIABLES
1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
2. Statistically significant changes in neuroimaging tests.
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.
STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.
POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).
Detailed Description:
BACKGROUND AND RATIONALE Several authors have described specific cognitive damage following cancer treatments (often chemotherapy and radiotherapy), which has been termed "chemo-brain". This condition produces alterations in different neurocognitive fields such as memory, learning, concentration, reasoning, executive functions, attention and visuospatial skills.
In this research project the investigator team propose an intervention aimed at one of the most limiting adverse effects of cancer and its treatment such as neurocognitive deficits through technological game platforms and brain training used in a directed, controlled and supervised manner.
HYPOTHESIS
1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.
VARIABLES
1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests: TAVECI/TAVEC, CATA, TONI-4 (form A), Digits, SDMT, ROCF, TFV, Stroop, Vocabulary
2. Statistically significant changes in neuroimaging tests. The following variables will be measured:
1. Structural imaging: volume measurement and Voxel Based Morphometry
2. Diffusion Imaging: diffusion maps and structural connectivity
3. Functional imaging: resting state and task based fMRI
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment:
1. Study of lymphocyte populations by parametric flow cytometry: T lymphocytes, B lymphocytes, natural killer (NK) lymphocytes, NK T lymphocytes
2. Study of inflammatory cytokines by LUMINEX: IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17TH, IL-1R antagonist
STUDY DESIGN
In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors, patients will follow the following phases:
* Informed consent
* Recruitment, inclusion and exclusion criteria.
* Initial T0 assessment
* Randomization
* Treatment phase for the intervention group. Waiting phase for control group
* Early post-treatment evaluation T+3
* Late post-treatment evaluation T+6
POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).
TREATMENT OF THE STUDY Type of intervention
Cognitive training through 3 types of video games:
* "Serious games" or "brain-training games".
* Exer-gaming
* Skill-training games Method of administration
The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern:
* "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week.
* "Exer-gaming": sessions of 15-20 minutes 2 days a week.
* "Skill-training games": sessions of 15-20 minutes 2 days a week.
SAMPLE SIZE It is planned to recruit 56 patients (28 patients for each group, of which 14 will be from the 8-12 years age group and 14 will be from the 13-17 years age group). Recruitment will be for 12 months, with a follow-up period for each patient of 6 months.
In this research project the investigator team propose an intervention aimed at one of the most limiting adverse effects of cancer and its treatment such as neurocognitive deficits through technological game platforms and brain training used in a directed, controlled and supervised manner.
HYPOTHESIS
1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.
VARIABLES
1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests: TAVECI/TAVEC, CATA, TONI-4 (form A), Digits, SDMT, ROCF, TFV, Stroop, Vocabulary
2. Statistically significant changes in neuroimaging tests. The following variables will be measured:
1. Structural imaging: volume measurement and Voxel Based Morphometry
2. Diffusion Imaging: diffusion maps and structural connectivity
3. Functional imaging: resting state and task based fMRI
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment:
1. Study of lymphocyte populations by parametric flow cytometry: T lymphocytes, B lymphocytes, natural killer (NK) lymphocytes, NK T lymphocytes
2. Study of inflammatory cytokines by LUMINEX: IL-2, IL-4, IL-6, TNF alpha, IFN gamma, IL-10, IL-17TH, IL-1R antagonist
STUDY DESIGN
In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors, patients will follow the following phases:
* Informed consent
* Recruitment, inclusion and exclusion criteria.
* Initial T0 assessment
* Randomization
* Treatment phase for the intervention group. Waiting phase for control group
* Early post-treatment evaluation T+3
* Late post-treatment evaluation T+6
POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT).
TREATMENT OF THE STUDY Type of intervention
Cognitive training through 3 types of video games:
* "Serious games" or "brain-training games".
* Exer-gaming
* Skill-training games Method of administration
The patient will receive the treatment for a period of 12 weeks, in which they will commit to use the video games of the intervention with the following pattern:
* "Brain-training game": sessions of 7-12 minutes with a frequency of 4 days a week.
* "Exer-gaming": sessions of 15-20 minutes 2 days a week.
* "Skill-training games": sessions of 15-20 minutes 2 days a week.
SAMPLE SIZE It is planned to recruit 56 patients (28 patients for each group, of which 14 will be from the 8-12 years age group and 14 will be from the 13-17 years age group). Recruitment will be for 12 months, with a follow-up period for each patient of 6 months.
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?: