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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04565769
Other study ID # 2016-051-000001-1730
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 12, 2020
Est. completion date March 2025

Study information

Verified date April 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
Aarhus University Hospital University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention 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) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Attention Changes in attention as measured with Paced Auditory Serial Addition Test (scores ranging from a minimum of 0 and a maximum of 60 with higher scores indicating a better outcome) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Processing Speed Changes in processing speed as measured with WAIS-IV The Digit Symbol coding (scores ranging from a minimum of 0 and a maximum of 135 with higher scores indicating a better outcome) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Processing Speed Changes in processing speed as measured with Trail Making Test A (outcome is time in seconds) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Working memory Changes in working memory as measured with WAIS-IV The Digit Span Backwards (scores with a minimum of 0 points to a maximum of 16 points - higher scores mean a better outcome) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Working memory Changes in working memory as measured with WAIS-IV The Digit Span Ranking (scores with a minimum of 0 points to a maximum of 16 points - higher scores mean a better outcome) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Learning and memory Changes in learning and memory as measured with the Hopkins Verbal Learning Test - Revised (part 1 include a minimum score of 0 and a maximum score of 36 with higher score indicating a better outcome, part 2 include a minimum score of 0 and a maximum score of 12 with higher scores indicating better outcomes) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Learning and memory Changes in learning and memory as measured with Brief Visuospatial Memory Test - Revised (part 1 include a minimum score of 0 and a maximum score of 18 with a higher score indicating a better outcome, part 2 include a minimum score of 0 and a maximum score of 6 with higher scores indicating better outcomes) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Visuospatial ability Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning (scores with a minimum of 0 and a maximum of 26 with higher scores indicating better outcomes) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Verbal fluency Changes in verbal fluency as measured with the Controlled Oral Word Association Test, letter and animal (as many words as possible, more words indicating a better outcome. No maximum value) Baseline, and week 8, 24 and 12 weeks after completed treatment
Primary Executive function Changes in executive function as measured with the Trail Making Test B (outcome is time in seconds) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Cancer-related fatigue Changes in fatigue severity as measured with The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT fatigue) scale (range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Sleep quality Changes in sleep quality as measured with the Insomnia Severity Index (ISI) (scores ranging from a minimum of 0 and a maximum of 28 with higher scores indicating higher levels of insomnia) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Sleep quality Changes in sleep quality as measured with the Pittsburgh Sleep Quality Index (PSQI) (scores ranging form a minimum of 0 indicating no difficulty and a maximum of 21 indicating severe difficulties in all areas related to sleep) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Perceived cognitive functioning Changes in perceived cognitive functioning as measured with The Patient Assessment of Own Functioning Inventory (PAOFI) (outcome is scores ranging from a minimum of 35 to a maximum of 210) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Depression/Anxiety Changes in depression/anxiety as measured with the Hospital Anxiety and Depression Scale (HADS) (range from a minimum score of 0 to a maximum score of 21 in which a higher scores mean higher levels of depression/anxiety) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Sickness behavior Changes in subjective sickness behavior as measured with the Sickness Questionnaire (SicknessQ) (scores ranging from a minimum of 0 and a maximum of 30 with higher scores indicating worse outcome) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Health-related quality of life Changes in health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life questionnaire for cancer patients (EORTC QLQ-C30) (all of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.) Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Moderator: genotype Genotype of COMT and APOE4
Genotype of COMT
Baseline
Secondary Inflammatory immune markers TNF-a, IL-6, IL-8, IL-21, CRP, IP-10 and MCP-1 extracted from blood samples Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary Brain grey matter Changes in brain grey matter as measured with T1-weighted MRI Baseline and week 24.
Secondary Brain white matter Changes in brain white matter as measured with T1-weighted MRI Baseline and week 24.
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