Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Attention — 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)
• Attention — 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)
• Processing Speed — 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)
• Processing Speed — 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)
• Working memory — 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)
• Working memory — 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)
• Learning and memory — 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)
• Learning and memory — 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)
• Visuospatial ability — 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)
• Verbal fluency — 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)
• Executive function — 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)

Trial sites (1)

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