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Sleep and Immune Checkpoint Inhibitors

21 juli 2021 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

240

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

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

Studieorter

  • Danmark
    • Midtjylland
      • Aarhus, Midtjylland, Danmark, 8200
        • Rekrytering
        • Aarhus University Hospital
        • Kontakt:
        • Huvudutredare:
          • Louise Stroem, Ph.D-fellow

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

- Confirmed diagnosis of advanced non-small cell lung cancer

Exclusion Criteria:

  • Insufficient Danish proficiency
  • Pre-existing confounding psychiatric illnesses

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical response to treatment
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Insomnia Severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 18 weeks after initiation of treatment.
Objective sleep outcome: Circadian activity rhythms.
Baseline to 18 weeks after initiation of treatment.
Disease status
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Aarhus University Hospital

Samarbetspartners

University of Aarhus

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 augusti 2019

Primärt slutförande (Förväntat)

1 september 2022

Avslutad studie (Förväntat)

1 november 2022

Studieregistreringsdatum

Först inskickad

23 augusti 2019

Först inskickad som uppfyllde QC-kriterierna

26 augusti 2019

Första postat (Faktisk)

28 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juli 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juli 2021

Senast verifierad

1 juli 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Sleep.ICI

Plan för individuella deltagardata (IPD)

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