Trial Title:
Technological Gaming in Cancer Survivors (WINNERS)
NCT ID:
NCT06312969
Condition:
Survivors of Childhood Cancer
Conditions: Keywords:
Cancer Survivors
Survivors of Childhood Cancer
Chemotherapy-related Cognitive Impairment
Functional Magnetic Resonance Imaging (fMRI)
Video Games
Exergaming
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized versus control group clinical trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Video game based training
Description:
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.
Arm group label:
Intervention group with video game-based training
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients between 8 and 17 years of age at the time of recruitment.
- Have completed treatment between 1 and 6 years prior to recruitment.
- Have had one of the following diagnoses:
- Patients with CNS disease (posterior fossa tumors and supratentorial gliomas
smaller than 1 cm affecting associative areas).
- Patients with hematologic malignancies (leukemia or lymphoma).
- Patients with solid tumors.
- Patients with non-malignant hematological diseases and indication for
allogeneic hematopoietic progenitor transplantation.
- Having received at least one of the following treatments:
- Central nervous system surgery.
- Central nervous system radiotherapy.
- Intrathecal/intraventricular chemotherapy.
- Neurotoxic systemic chemotherapy.
- Hematopoietic stem cell transplantation.
- Informed consent signed by parent/guardian.
Exclusion Criteria:
- Active oncologic disease or relapse of active oncologic disease.
- Prior neurological or psychiatric pathology that may preclude trial or treatment
evaluations:
- Psychological or neurocognitive illness or sequelae that preclude
neuropsychological assessment or are expected to significantly artifact MRI
results (examples: significant decrease in visual acuity, CNS surgical scar
that artifacts imaging results, severe cognitive delay that precludes testing,
etc.).
- Psychological or neurocognitive illnesses or sequelae that prevent or
contraindicate the use of video games (epilepsy that prevents the use of
screens, significant decrease in visual acuity, etc.).
- Mild or self-limiting neurological or psychiatric pathology that does not
interfere with trial diagnosis and treatment (headache, epilepsy in remission
with effective treatment, mild cognitive delay, etc.) will be allowed.
- Current or recent (less than 1 year) use of other cognitive stimulation or brain
training that may interfere with study results.
- Refusal to abstain from the use of the study treatment games in case of being
assigned to group B (control group).
- Medical treatment that may significantly interfere with neuropsychological, imaging
or biomarker assessments.
Gender:
All
Minimum age:
8 Years
Maximum age:
17 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Carlos Gonzalez-Perez, MD
Phone:
0034917277223
Email:
carlos.gonzalez2@salud.madrid.org
Investigator:
Last name:
Antonio Perez-Martinez, PhD, MD
Email:
Principal Investigator
Investigator:
Last name:
Carlos R Gonzalez-Perez, MD
Email:
Sub-Investigator
Investigator:
Last name:
Eduardo Fernandez, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Elena Moran
Email:
Sub-Investigator
Investigator:
Last name:
Juan Alvarez
Email:
Sub-Investigator
Investigator:
Last name:
Norberto Malpica
Email:
Sub-Investigator
Investigator:
Last name:
Diego Plaza, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mario Alonso
Email:
Sub-Investigator
Start date:
February 23, 2023
Completion date:
February 2025
Lead sponsor:
Agency:
Antonio Pérez Martínez
Agency class:
Other
Collaborator:
Agency:
Hospital Ruber Internacional
Agency class:
Other
Collaborator:
Agency:
Universidad Rey Juan Carlos
Agency class:
Other
Source:
Instituto de Investigación Hospital Universitario La Paz
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06312969
