Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Sleep and Immune Checkpoint Inhibitors

21. Juli 2021 aktualisiert von: Louise Strøm, Aarhus University Hospital

Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

240

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Robert Zachariae, Prof., DMSc
  • Telefonnummer: 0045 87165878
  • E-Mail: bzach@aarhus.rm.dk

Studienorte

  • Dänemark
    • Midtjylland
      • Aarhus, Midtjylland, Dänemark, 8200
        • Rekrutierung
        • Aarhus University Hospital
        • Kontakt:
        • Hauptermittler:
          • Louise Stroem, Ph.D-fellow

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Men and women diagnosed with advanced non-small cell lung cancer, treated with immune checkpoint inhibitors, at Aarhus University Hospital, Denmark.

Beschreibung

Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

  • Insufficient Danish proficiency
  • Pre-existing confounding psychiatric illnesses

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical response to treatment
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Insomnia Severity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome. Nightly sleep onset latency (SOL)
Baseline to 18 weeks after initiation of treatment.
Actigraphy 2
Zeitfenster: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Wakefulness after initial sleep onset (WASO)
Baseline to 18 weeks after initiation of treatment.
Actigraphy 3
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Actigraphy 6
Zeitfenster: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Circadian activity rhythms.
Baseline to 18 weeks after initiation of treatment.
Disease status
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aarhus University Hospital

Mitarbeiter

University of Aarhus

Ermittler

  • Studienleiter: Robert Zachariae, Prof., DMSc, Aarhus University and Aarhus University Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. August 2019

Primärer Abschluss (Voraussichtlich)

1. September 2022

Studienabschluss (Voraussichtlich)

1. November 2022

Studienanmeldedaten

Zuerst eingereicht

23. August 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. August 2019

Zuerst gepostet (Tatsächlich)

28. August 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2021

Zuletzt verifiziert

1. Juli 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Sleep.ICI

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Lungenkrebs

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Belarus

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren