Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Sleep and Immune Checkpoint Inhibitors

21. juli 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Forventet)

240

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

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

Studiesteder

  • Danmark
    • Midtjylland
      • Aarhus, Midtjylland, Danmark, 8200
        • Rekruttering
        • Aarhus University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Louise Stroem, Ph.D-fellow

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

  • Insufficient Danish proficiency
  • Pre-existing confounding psychiatric illnesses

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical response to treatment
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Insomnia Severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Circadian activity rhythms.
Baseline to 18 weeks after initiation of treatment.
Disease status
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aarhus University Hospital

Samarbeidspartnere

University of Aarhus

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. august 2019

Primær fullføring (Forventet)

1. september 2022

Studiet fullført (Forventet)

1. november 2022

Datoer for studieregistrering

Først innsendt

23. august 2019

Først innsendt som oppfylte QC-kriteriene

26. august 2019

Først lagt ut (Faktiske)

28. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Sleep.ICI

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Lungekreft

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Oman

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere