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NCT Number: NCT04565769

Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Melanoma Anxiety Disorders Behavior Behavioral Symptoms Cancer-related Cognitive Impairment Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depression Depression, Anxiety Fatigue Illness Behavior Inflammation Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neurocognitive Disorders Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Sickness Behavior Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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:

  • Changes in cognitive functions over the course of treatment with ICIs.
  • Possible associations between changes in cognitive function and immune markers during and following ICI treatment.
  • Possible associations between changes in cognitive function and changes in brain morphology.
  • Changes over time in other possible adverse effects of ICI treatment, including psychological distress, sleep disturbances, and fatigue.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Attention

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  2. Attention

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  3. Processing Speed

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  4. Processing Speed

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    Changes in processing speed as measured with Trail Making Test A (outcome is time in seconds)

  5. Working memory

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  6. Working memory

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  7. Learning and memory

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  8. Learning and memory

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  9. Visuospatial ability

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  10. Verbal fluency

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  11. Executive function

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    Changes in executive function as measured with the Trail Making Test B (outcome is time in seconds)

Secondary outcomes

  1. Cancer-related fatigue

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  2. Sleep quality

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  3. Sleep quality

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  4. Perceived cognitive functioning

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  5. Depression/Anxiety

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  6. Sickness behavior

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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)

  7. Health-related quality of life

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    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.)

  8. Moderator: genotype

    Time frame: Baseline

    Genotype of COMT and APOE4

    Genotype of COMT

  9. Inflammatory immune markers

    Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment

    TNF-α, IL-6, IL-8, IL-21, CRP, IP-10 and MCP-1 extracted from blood samples

  10. Brain grey matter

    Time frame: Baseline and week 24.

    Changes in brain grey matter as measured with T1-weighted MRI

  11. Brain white matter

    Time frame: Baseline and week 24.

    Changes in brain white matter as measured with T1-weighted MRI

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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