Trials / Active Not Recruiting

Active Not RecruitingNCT04565769

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

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 100 (actual)

Sponsor: Aarhus University Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

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.

Detailed description

This controlled prospective observational study will include two groups with a total of 84 participants. A total of 42 patients diagnosed with melanoma, referred to treatment with ICI will be enrolled in the study and examined prior to treatment with ICI (baseline), at eight weeks following baseline (T2), at 24 weeks following baseline (T3) and 12 weeks after treatment completed (T4). A total of 42 gender- and age- matched healthy controls will be included and assessed at similar time points. Assessments will include a battery of neuropsychological tests, questionnaires, blood samples, and Magnetic Resonance Imaging (MRI). The main objectives of the study are to investigate: 1. Changes in cognitive functions over the course of treatment with ICIs. 2. Possible associations between changes in cognitive function and immune markers during and following ICI treatment. 3. Possible associations between changes in cognitive function and changes in brain morphology. 4. Changes over time in other possible adverse effects of ICI treatment, including psychological distress, sleep disturbances, and fatigue.

Conditions

Timeline

Start date: 2020-11-12
Primary completion: 2025-03-01
Completion: 2025-03-01
First posted: 2020-09-25
Last updated: 2024-12-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04565769. Inclusion in this directory is not an endorsement.