Sleep and Immune Checkpoint Inhibitors

NCT ID: NCT04070651

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2023-07-01

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria

• Insufficient Danish proficiency
• Pre-existing confounding psychiatric illnesses

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Louise Strøm

PhD-fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Zachariae, Prof., DMSc

Role: STUDY_DIRECTOR

Aarhus University and Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

Sleep.ICI

Identifier Type: -

Identifier Source: org_study_id