Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma
Cognitive Impairment in Patients With Diffuse Large B-cell Lymphoma
Institute of Oncology Ljubljana
3 participants
Jan 1, 2022
INTERVENTIONAL
Conditions
Summary
This prospective, non-randomized diagnostic interventional study evaluates cognitive impairment in patients with diffuse large B-cell lymphoma (DLBCL) treated at the Institute of Oncology Ljubljana. Chemotherapy regimens are administered according to clinical indication and are not assigned by the study protocol. The research intervention consists of structured neurocognitive assessments and biomarker analyses performed at predefined time points during treatment and follow-up. Cognitive function will be assessed at baseline, after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, cerebrospinal fluid (CSF) biomarkers will be analyzed using samples collected during clinically indicated lumbar punctures. The study aims to characterize the frequency, severity, and trajectory of cognitive impairment and to identify clinical and biological predictors of treatment-associated cognitive changes in patients with DLBCL.
Eligibility
Inclusion Criteria4
- Adults aged 18 to 80 years
- Newly diagnosed diffuse large B-cell lymphoma (DLBCL) planned for treatment with systemic chemotherapy (R-CHOP) with or without intrathecal chemotherapy
- Ability to provide written informed consent
- For healthy volunteer/control group: relatives of participating patients willing to undergo cognitive testing and questionnaires
Exclusion Criteria4
- Severe cognitive impairment preventing completion of neurocognitive testing
- Severe psychiatric disorder or neurological disease interfering with cognitive assessment
- Inability to understand study procedures or complete questionnaires
- Refusal or inability to provide informed consent
Interventions
Standardized neurocognitive testing including Montreal Cognitive Assessment (MoCA), Short Cognitive Performance Test (KPSS), and selected CANTAB computerized tasks assessing attention, working memory, executive function, processing speed, and episodic memory. Assessments are performed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation.
Validated questionnaires assessing anxiety, depression, fatigue, cognitive complaints, and quality of life (HADS, HAM-D, FSS, FACT-Cog v3, EORTC QLQ-C30, ECOG Performance Status). Questionnaires are administered at predefined study time points.
Quantification of cerebrospinal fluid biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP). CSF samples are collected during clinically indicated lumbar punctures prior to intrathecal chemotherapy administration. No additional lumbar punctures are performed solely for research purposes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07443514