Actively Recruiting
Led by Rigshospitalet, Denmark · Updated on 2023-05-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating cognitive impairment in children, adolescents, and young adults aged 7 to 29 years who are receiving chemotherapy for cancer outside the brain. The study aims to understand changes in thinking skills like memory and attention, brain electrical activity, and biological markers linked to brain function. This research seeks to better describe how cognitive abilities change during and after chemotherapy treatment in young cancer patients. Participants include patients with various types of cancer and matched healthy controls from their social circles. Assessments occur at several time points: near diagnosis, during chemotherapy (up to three times), at the end of treatment, and six months later. Additional testing is done for patients receiving high-dose methotrexate. The study collects neuropsychological test results, quality of life and fatigue questionnaires, EEG brain recordings, event-related potentials, and blood or cerebrospinal fluid samples to measure brain-related biomarkers. Throughout the study, patients and matched controls undergo cognitive testing, EEG sessions, and questionnaires at specified times. Blood samples are collected at key chemotherapy cycles to analyze markers of brain injury and inflammation. Researchers analyze changes over time in cognitive scores, brain activity, quality of life, fatigue, and biomarkers to explore how chemotherapy affects brain function. The total participation period includes assessments from diagnosis up to six months after treatment ends, with data compared between patients and healthy controls.
CONDITIONS
Investigating Cognitive Impairment in Young Patients With Cancer Prospectively
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 30 days from diagnosis
Participants are assessed close to the day of cancer diagnosis, including neuropsychological tests, quality of life and fatigue questionnaires, EEG recordings, and biomarker sampling.
1 visit (in-person)
Duration - Varies depending on treatment protocol (up to several years)
Participants undergoing chemotherapy have biological samples collected immediately before and 10-14 days after major chemotherapy cycles and high dose methotrexate treatments to monitor biomarkers associated with cognitive functioning.
Up to 3 visits during major chemotherapy treatments and 3 visits during high dose methotrexate treatments
Duration - Assessment around 2 weeks after end of treatment
Participants are assessed approximately two weeks after completing their final antineoplastic treatment to evaluate cognitive function, quality of life, fatigue, EEG, and biomarkers.
1 visit (in-person)
Duration - 6 months after end of treatment
Participants are reassessed 6 months after end of treatment to monitor long-term cognitive function, quality of life, fatigue, EEG, and biomarkers.
1 visit (in-person)
Total: 1 location
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
L
Lisa L Hjalgrim, PhD, MD
B
Barbara Nordhjem, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Barbara Johanne Thomas Nordhjem, Morten Tjørnlund, Birthe Lykke Thomsen...
https://pubmed.ncbi.nlm.nih.gov/37202143