Clinical trial NCT04565769: Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors
Official title: Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Cognitive Impairment
Fatigue
Sleep
Depression, Anxiety
Quality of Life
Inflammation
Sickness Behavior
Cancer-related Cognitive Impairment
Keywords: Immune Checkpoint Inhibitors
Melanoma
Cancer-related Symptoms
Cognitive Dysfunction
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2020-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with melanoma and scheduled for ICI treatment at Aarhus University Hospital, Denmark. Controls will be healthy volunteers of cancer-free participants matched on age and gender.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attention
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Attention
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Processing Speed
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Processing Speed
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Working memory
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Working memory
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Learning and memory
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Learning and memory
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Visuospatial ability
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Verbal fluency
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Executive function
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary outcomes:
measure: Cancer-related fatigue
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Sleep quality
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Sleep quality
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Perceived cognitive functioning
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Depression/Anxiety
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Sickness behavior
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Health-related quality of life
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Moderator: genotype
timeFrame: Baseline
measure: Inflammatory immune markers
timeFrame: Baseline, and week 8, 24 and 12 weeks after completed treatment
measure: Brain grey matter
timeFrame: Baseline and week 24.
measure: Brain white matter
timeFrame: Baseline and week 24.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: