Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

NCT04565769 | Active Not Recruiting DMC

• 1 other identifier: 2016-051-000001-1730
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• Cancer-related fatigue

  Baseline, and week 8, 24 and 12 weeks after completed treatment

• Sleep quality

  Baseline, and week 8, 24 and 12 weeks after completed treatment

• Sleep quality

  Baseline, and week 8, 24 and 12 weeks after completed treatment

• Perceived cognitive functioning

  Baseline, and week 8, 24 and 12 weeks after completed treatment

• Depression/Anxiety

  Baseline, and week 8, 24 and 12 weeks after completed treatment

Study Arms (2)

Cancer patients with melanoma

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

Healthy controls

Fifthy three age- and gender- matched healthy controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Melanoma; Cognitive Dysfunction; Fatigue; Depression; Anxiety Disorders; Inflammation; Illness Behavior

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.psych., Ph.d.-fellow

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 25, 2020
• Study Start: November 12, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

DK (1)