Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Sleep and Immune Checkpoint Inhibitors

21. července 2021 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Očekávaný)

240

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Robert Zachariae, Prof., DMSc
  • Telefonní číslo: 0045 87165878
  • E-mail: bzach@aarhus.rm.dk

Studijní místa

  • Dánsko
    • Midtjylland
      • Aarhus, Midtjylland, Dánsko, 8200
        • Nábor
        • Aarhus University Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Louise Stroem, Ph.D-fellow

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

  • Insufficient Danish proficiency
  • Pre-existing confounding psychiatric illnesses

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical response to treatment
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Insomnia Severity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Circadian activity rhythms.
Baseline to 18 weeks after initiation of treatment.
Disease status
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Aarhus University Hospital

Spolupracovníci

University of Aarhus

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. srpna 2019

Primární dokončení (Očekávaný)

1. září 2022

Dokončení studie (Očekávaný)

1. listopadu 2022

Termíny zápisu do studia

První předloženo

23. srpna 2019

První předloženo, které splnilo kritéria kontroly kvality

26. srpna 2019

První zveřejněno (Aktuální)

28. srpna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2021

Naposledy ověřeno

1. července 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Sleep.ICI

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Rakovina plic

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Senegal

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit