Investigating Cognitive Impairment in Young Patients With Cancer Prospectively

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-29
SponsorRigshospitalet, Denmark

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Solid tumor patients
Group B: Haematological patients

Trial outcomes

Primary outcomes

1

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.

Time frame
T0: within 30 days of diagnosis
2

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.

Time frame
T2: end of treatment (2 weeks after the final antineoplastic treatment)
3

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.

Time frame
T3: 6 months after end of treatment

Secondary outcomes

1

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.

Time frame
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
2

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.

Time frame
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
3

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.

Time frame
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
4

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.

Time frame
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment

Other outcomes

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