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Sleep and Immune Checkpoint Inhibitors

21 juli 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

240

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Robert Zachariae, Prof., DMSc
  • Telefoonnummer: 0045 87165878
  • E-mail: bzach@aarhus.rm.dk

Studie Locaties

  • Denemarken
    • Midtjylland
      • Aarhus, Midtjylland, Denemarken, 8200
        • Werving
        • Aarhus University Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Louise Stroem, Ph.D-fellow

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

  • Insufficient Danish proficiency
  • Pre-existing confounding psychiatric illnesses

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical response to treatment
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Insomnia Severity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Circadian activity rhythms.
Baseline to 18 weeks after initiation of treatment.
Disease status
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aarhus University Hospital

Medewerkers

University of Aarhus

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 augustus 2019

Primaire voltooiing (Verwacht)

1 september 2022

Studie voltooiing (Verwacht)

1 november 2022

Studieregistratiedata

Eerst ingediend

23 augustus 2019

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2019

Eerst geplaatst (Werkelijk)

28 augustus 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Sleep.ICI

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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