- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070651
Sleep and Immune Checkpoint Inhibitors
Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients
Study Overview
Status
Conditions
Detailed Description
A total of 240 cancer patients diagnosed with advanced NSCLC, referred to treatment with ICI will be enrolled in this prospective observational study. Patients will be assessed prior to initiation of treatment (baseline) and every third subsequent week, corresponding to each treatment cycle over a period of 18 weeks. Assessments will include questionnaires, sleep diaries, actigraphy, and blood and saliva samples to examine sleep, fatigue, psychological and physical symptoms, the sleep-wake-cycle, inflammation, and cortisol. Additionally, the patients will be asked to complete a reduced questionnaire every week within the 18 weeks period, to address weekly fluctuations in sleep quality, fatigue, and mood. Treatment response is assessed after 9 and 18 weeks.
Aims:
- To explore possible associations between sleep and the clinical response to treatment with ICI.
- To investigate the prevalence of sleep disturbance in patients with NSCLC during treatment with ICI.
- To prospectively assess changes in sleep parameters over the course of treatment.
- To examine associations between sleep parameters and fatigue, depression, anxiety, and inflammation.
- To explore possible associations between sleep, fatigue, depression, inflammatory responses and the clinical response to treatment with ICIs.
Hypotheses:
Patients with high levels of sleep disturbance (insomnia severity) will experience 1) poorer clinical response to ICI, 2) more depressive symptoms, 3) higher levels of fatigue, 4) poorer overall health-related quality of life (HRQoL), 5) higher levels of inflammation.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Louise Stroem, MSc
- Phone Number: 0045 8716 5076
- Email: louisestroem@psy.au.dk
Study Contact Backup
- Name: Robert Zachariae, Prof., DMSc
- Phone Number: 0045 87165878
- Email: bzach@aarhus.rm.dk
Study Locations
-
-
Midtjylland
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Aarhus, Midtjylland, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Peter Meldgaard, MD, Ph.D
- Phone Number: +45 78454836
- Email: pmeldgaard@oncology.au.dk
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Principal Investigator:
- Louise Stroem, Ph.D-fellow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Confirmed diagnosis of advanced non-small cell lung cancer
Exclusion Criteria:
- Insufficient Danish proficiency
- Pre-existing confounding psychiatric illnesses
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response to treatment
Time Frame: Changes from baseline to 9 and 18 weeks after treatment initiation, respectively.
|
Radiological evaluation of the clinical response to treatment with ICI, according to RECIST criteria.
|
Changes from baseline to 9 and 18 weeks after treatment initiation, respectively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity
Time Frame: Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in insomnia severity as measured with The Insomnia Severity Index (ISI).
Total score ranges from 0 to 28.
Interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
|
Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Sleep diary
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Changes in Standard sleep metrics (nightly sleep onset latency (SOL), wakefulness after initial sleep onset (WASO), total sleep time (TST), total time spent in bed (TIB), sleep efficiency (SE).
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Fatigue
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in subjective fatigue as measured with the Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF).
Subscales (general, physical, emotional, and mental fatigue) are summed and the vigor scale subtracted to create a fatigue total score, with higher scores indicating higher levels of fatigue.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Depressive symptoms
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in depressive symptoms as measured with the Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression - Short Form 8a.
Total raw score ranges from 8 to 40, with higher scores indicating greater severity of depression.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Health-related quality of life
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
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).
The standardized raw score, ranges from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Disease specific health-related quality of life
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in disease specific health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life Lung Cancer Module (EORTC QLQ-LC29).
The standardized raw score, ranges from 0 to 100; a high score for the symptom scales / single items represents a high level of symptomatology or problems.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Perceived Stress
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in perceived stress as measured with The Perceived Stress Scale (PSS).
Total score ranges from 0 to 40, with higher scores indicating higher perceived stress.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Sickness behavior
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Changes in subjective sickness behavior as measured with the Sickness Questionnaire (SicknessQ).
Total score ranges from 0 to 30, with higher scores indicating more sickness behaviour.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
|
Cortisol
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Cortisol awakening response (CAR), and the diurnal cortisol slope (DCS)
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Inflammatory response 1
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
CRP
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Inflammatory response 2
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
IL-6
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Inflammatory response 3
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
TNF-a
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Inflammatory response 4
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Se-Cortisol
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Inflammatory response 5
Time Frame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
White blood cell count.
|
Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
|
Actigraphy 1
Time Frame: Baseline to 18 weeks after initiation of treatment.
|
Objective sleep outcome.
Nightly sleep onset latency (SOL)
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Baseline to 18 weeks after initiation of treatment.
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Actigraphy 2
Time Frame: Baseline to 18 weeks after initiation of treatment.
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Objective sleep outcome: Wakefulness after initial sleep onset (WASO)
|
Baseline to 18 weeks after initiation of treatment.
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Actigraphy 3
Time Frame: Baseline to 18 weeks after initiation of treatment.
|
Objective sleep outcome: Total sleep time (TST)
|
Baseline to 18 weeks after initiation of treatment.
|
Actigraphy 4
Time Frame: Baseline to 18 weeks after initiation of treatment.
|
Objective sleep outcome: Total time spent in bed (TIB)
|
Baseline to 18 weeks after initiation of treatment.
|
Actigraphy 5
Time Frame: Baseline to 18 weeks after initiation of treatment.
|
Objective sleep outcome: Sleep efficiency (SE, i.e., the percent of the time asleep out of amount of time spent in bed)
|
Baseline to 18 weeks after initiation of treatment.
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Actigraphy 6
Time Frame: Baseline to 18 weeks after initiation of treatment.
|
Objective sleep outcome: Circadian activity rhythms.
|
Baseline to 18 weeks after initiation of treatment.
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Disease status
Time Frame: 1, 2 and 3 years from treatment initiation (baseline).
|
Changes in disease status after treatment initiation with ICI.
Changes are evaluated according to RECIST criteria.
|
1, 2 and 3 years from treatment initiation (baseline).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Robert Zachariae, Prof., DMSc, Aarhus University and Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sleep.ICI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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