About this trial
The MyBrain study investigates the brain function of children, adolescents and young adults during and after chemo treatment for cancer. The tests include 1) cognitive skills such as memory and attention; 2) the brain's electrical activity; 3) and biological markers related to brain function.
The aim of the study is to better understand the trajectories of cognitive functioning and measures that have been associated with cognitive impairment in patients treated with chemotherapy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients who are newly diagnosed with a non-CNS cancer and will undergo chemotherapy at University Hospital Copenhagen, Rigshospitalet.
At the age of 7-29 years at diagnosis
Each patient is matched (1:1) with a control participant within 24 months of age. The controls are recruited from the patient's own social circle and can be a friend, partner, or close family (sibling or cousin).
Disqualifiers
Unable to speak and understand Danish
Severe intellectual disability or mental health disorder that hinders participation
Brain metastases,
Terminal illness
Trial population
Patients who are diagnosed with a non-central nervous system cancer at Rigshospitalet in Copenhagen, Denmark. The distribution of different cancer diagnoses in the study population will reflect the distribution of non-CNS diagnoses among patients in the age group receiving chemotherapy at the study site. The most common diagnoses are Hodgkin lymphoma, non-Hodgkin lymphoma, testicular cancer, sarcoma, and leukaemia. Approximately 30-40 new patients are expected to be included every year (in total 100 patients during the three-year recruitment period).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
Secondary outcomes
Trajectories of performance on clinical neurocognitive tests: Grooved Pegboard test
The Grooved Pegboard (Lafayette Instrument) is a neurocognitive test consisting of consisting of key shapes (pegs) and matching holes used to test visual-motor coordination. Scores are in milliseconds, lower scores = better performance.
Trajectories of performance on clinical neurocognitive tests: Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests List Learning, List Recall and List Recognition evaluates learning and memory. Scaled scores (t-scores) range from 0-100, higher = better performance.
Trajectories of performance on clinical neurocognitive tests: Conner's Continuous Performance Test
The Conner's Continuous Performance Test Third edition evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance. Scaled scores (t-scores) range from 0-100, higher = better performance.
Trajectories of performance on clinical neurocognitive tests: NEPSY-II, A Developmental Neuropsychological Assesment of Neuropsychological Status
The NEPSY Second edition Verbal Fluency subtest is used to evaluate executive and verbal cognitive skills. The scores are the number of correct words generated for the two semantic and two lexical fluency tasks, rang 0-no upper limit, more words = higher score.
Sponsors and contacts
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