Sleep and Immune Checkpoint Inhibitors

NCT04070651 | Completed

• 1 other identifier: Sleep.ICI
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Sleep; Fatigue; Depressive symptoms; Immune Checkpoint Inhibitors; Lung Cancer; Clinical response

Outcome Measures

Primary Outcomes (1)

• Clinical response to treatment

  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 Outcomes (21)

• Insomnia Severity

  Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.

• Sleep diary

  Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.

• 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

  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

  Baseline, and week 3, 6, 9, 12, 15 and 18, respectively, and follow-up 1, 2 and 3 years from baseline, respectively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Confirmed diagnosis of advanced non-small cell lung cancer

You may not qualify if:

• Insufficient Danish proficiency
• Pre-existing confounding psychiatric illnesses

Sponsors & Collaborators

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

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and saliva

MeSH Terms

Conditions

Lung Neoplasms; Fatigue; Depression

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Robert Zachariae, Prof., DMSc

  Aarhus University and Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-fellow

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: August 5, 2019
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

DK (1)