Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

Aarhus University Hospital

Status: Active, not recruiting

Conditions: Sickness Behavior; Inflammation; Melanoma; Cognitive Impairment; Quality of Life; Depression, Anxiety; Fatigue; Cancer-related Cognitive Impairment; Sleep

Study type: Observational

Funder types: Other

Identifiers

NCT04565769

2016-051-000001-1730

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Cancer patients with melanoma

Description:

Forty seven cancer patients with melanoma included prior to treatment with ICI.

Healthy controls

Description:

Fifthy three age- and gender- matched healthy controls.