Clinical trial · Observational
Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors
Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immune checkpoint inhibitors (ICIs) are a group of novel immunotherapies that boost the body's own defense against the cancer by improving the immune system's ability to recognize and destroy cancer cells. While it is relatively well-documented that conventional cancer treatments (e.g., chemotherapy) are associated with cognitive impairment, virtually nothing is yet known about effects on cognition during and after ICI treatment. Due to significantly improved survival rates after ICI treatments, it becomes important to map possible adverse effects associated with these treatments. The investigators therefore investigate possible changes in cognitive function in a group of cancer patients from prior to ICI treatment to nine months later. A gender- and age- matched healthy control group will serve as a comparison. The study has the potential to broaden our understanding of associations between cognition, the brain, and the immune system and to provide clinically relevant knowledge about possible cognitive impairments associated with immunotherapy.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Cognitive Impairment | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Depression, Anxiety | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
| Sickness Behavior | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cancer patients with melanoma
- description
- Forty seven cancer patients with melanoma included prior to treatment with ICI.
- label
- Healthy controls
- description
- Fifthy three age- and gender- matched healthy controls.
Primary outcomes (11)
- measure
- Attention
- timeFrame
- Baseline, and week 8, 24 and 12 weeks after completed treatment
- description
- Changes in attention as measured with WAIS-IV The Digit Span Forwards (scores with a minimum of 0 points to a maximum of 16 points - higher scores mean a better outcome)
- measure
- Attention
- timeFrame
- Baseline, and week 8, 24 and 12 weeks after completed treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of melanoma and scheduled for ICI treatment at Aarhus University Hospital (AUH), Denmark. The healthy control group will consist of an age- and gender- matched sample of participants. Exclusion Criteria: * Previous treatment with immunotherapy * Neurodegenerative diseases (dementia etc.) * Substance abuse * Known progressive psychiatric diseases (e.g., Schizophrenia) * Other confirmed diagnoses with underlying cognitive impairment * Insufficient Danish proficiency
References
Publications (0)
Data not yet available