Clinical trial NCT04070651: Sleep and Immune Checkpoint Inhibitors
Official title: Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Sleep
Fatigue
Depressive symptoms
Immune Checkpoint Inhibitors
Lung Cancer
Clinical response
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2019-08-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women diagnosed with advanced non-small cell lung cancer, treated with immune checkpoint inhibitors, at Aarhus University Hospital, Denmark.

Brief summary: Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.

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:

1. To explore possible associations between sleep and the clinical response to treatment with ICI.
2. To investigate the prevalence of sleep disturbance in patients with NSCLC during treatment with ICI.
3. To prospectively assess changes in sleep parameters over the course of treatment.
4. To examine associations between sleep parameters and fatigue, depression, anxiety, and inflammation.
5. 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.

Eligibility criteria: Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

* Insufficient Danish proficiency
* Pre-existing confounding psychiatric illnesses

Primary outcomes:
measure: Clinical response to treatment
timeFrame: Changes from baseline to 9 and 18 weeks after treatment initiation, respectively.
Secondary outcomes:
measure: Insomnia Severity
timeFrame: Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Sleep diary
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Fatigue
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Depressive symptoms
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Health-related quality of life
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Disease specific health-related quality of life
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Perceived Stress
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Sickness behavior
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.
measure: Cortisol
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Inflammatory response 1
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Inflammatory response 2
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Inflammatory response 3
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Inflammatory response 4
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Inflammatory response 5
timeFrame: Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
measure: Actigraphy 1
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Actigraphy 2
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Actigraphy 3
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Actigraphy 4
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Actigraphy 5
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Actigraphy 6
timeFrame: Baseline to 18 weeks after initiation of treatment.
measure: Disease status
timeFrame: 1, 2 and 3 years from treatment initiation (baseline).
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Midtjylland
Study officials:
affiliation: Aarhus University and Aarhus University Hospital
name: Robert Zachariae, Prof., DMSc
role: STUDY_DIRECTOR
References: