MelanomaNCT04565769
Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors
An observational study of Melanoma and Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Cognitive Impairment, Fatigue
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2020to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study
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.
Read the 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:
- 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.
- Conditions
- Melanoma, Cognitive Impairment, Fatigue, Sleep, Depression, Anxiety, Quality of Life
- Keywords
- Immune Checkpoint Inhibitors, Melanoma, Cancer-related Symptoms, Cognitive Dysfunction
- Medical subject headings
- Melanoma, Cognitive Dysfunction, Fatigue, Depression, Anxiety Disorders, Inflammation, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
Secondary outcomes (11)
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
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.)
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
Moderator: genotype
Genotype of COMT and APOE4
Genotype of COMT
Measured: Baseline
Inflammatory immune markers
TNF-α, IL-6, IL-8, IL-21, CRP, IP-10 and MCP-1 extracted from blood samples
Measured: Baseline, and week 8, 24 and 12 weeks after completed treatment
Brain grey matter
Changes in brain grey matter as measured with T1-weighted MRI
Measured: Baseline and week 24.
Brain white matter
Changes in brain white matter as measured with T1-weighted MRI
Measured: Baseline and week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start12 Nov 2020
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Josefine Tingdal Taube, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565769
- Sponsor's protocol ID
- 2016-051-000001-1730
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04565769
- Acronym / sponsor ID
- 2016-051-000001-1730
- Conditions
- Melanoma, Cognitive Impairment, Fatigue, Sleep, Depression, Anxiety, Quality of Life
- Keywords
- Immune Checkpoint Inhibitors, Melanoma, Cancer-related Symptoms, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous treatment with immunotherapy
- Neurodegenerative diseases (dementia etc.)
- Substance abuse
- Known progressive psychiatric diseases (e.g., Schizophrenia)
- Other confirmed diagnoses with underlying cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
11 secondary outcomes
Cancer-related fatigue
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Sleep quality
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Sleep quality
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Perceived cognitive functioning
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Depression/Anxiety
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Sickness behavior
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Health-related quality of life
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Moderator: genotype
Time frame: Baseline
Inflammatory immune markers
Time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment
Brain grey matter
Time frame: Baseline and week 24.
Brain white matter
Time frame: Baseline and week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention (time frame: Baseline, and week 8, 24 and 12 weeks after completed treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.