Evidence map›Paper›PMID 30591073›Full record

ArticleTrials2018

Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial.

Gunnhild Jakobsen, Morten Engstrøm, Ørnulf Paulsen, Karin Sjue, Sunil X Raj, Morten Thronæs, Marianne Jensen Hjermstad, Stein Kaasa, Peter Fayers, Pål Klepstad

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02807922 (Pharmacological Treatment of Insomnia in Palliative Care), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02807922 phase4completednot on this map

Pharmacological Treatment of Insomnia in Palliative Care: A Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial Investigating the Short Time Effect of Zopiclone on Self-reported Sleep Quality in Patients With Advanced Cancer Who Use Opioids and Who Report Insomnia

TypeinterventionalSponsorSt. Olavs HospitalRan2016 to 2021Enrolled43ConditionsSleep, InsomniaArmsZopiclone, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

Gunnhild JakobsenEuropean Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway. gunnhild.jakobsen@ntnu.no.
Morten EngstrømDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.
Ørnulf PaulsenEuropean Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.
Karin SjueDepartment of Oncology, Vestfold Hospital Trust, Tønsberg, Norway.
Sunil X RajEuropean Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.
Morten ThronæsEuropean Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.
Marianne Jensen HjermstadEuropean Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Stein KaasaEuropean Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Peter FayersDivision of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Pål KlepstadDepartment of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.
Norwegian University of Science and Technology · NOSt Olav's University Hospital · NOOslo University Hospital · NOSykehuset i Vestfold · NOTelemark Hospital · NOUniversity of Aberdeen · GBUniversity of Oslo · NO

Funding

Helse Midt-Norge 46083200
6 · The paper itself

Abstract

backgroundDespite the high prevalence of insomnia in patients with advanced cancer, there are no randomized controlled trials on pharmacological interventions for insomnia in this group of patients. A variety of pharmacological agents is recommended to manage sleep disturbance for insomnia in the general population, but their efficacy and safety in adults with advanced cancer are not established. Thus, there is a need to evaluate the effectiveness of medications for insomnia in order to improve the evidence in patients with advanced cancer. One of the most used sleep medications at present in patients with cancer is zopiclone.

methodsThis is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 100 patients with metastatic cancer who report insomnia will be randomly allocated to zopiclone or placebo. The treatment duration with zopiclone/placebo is 6 consecutive nights. The primary endpoint is patient-reported sleep quality during the final study night (night 6) assessed on a numerical rating scale of 0-10, where 0 = Best sleep and 10 = Worst possible sleep. Secondary endpoints include the mean patient-reported total sleep time and sleep onset latency during the final study night (night 6). DISCUSSION: Results from this study on treatment of insomnia in advanced cancer will contribute to clinical decision-making and improve the treatment of sleep disturbance in this patient cohort.

trial registrationClinicalTrials.gov, NCT02807922 . Registered on 21 June 2016.

Indexed as

Azabicyclo CompoundsClinical Trials, Phase IV as TopicDouble-Blind MethodDrug Administration ScheduleHumansHypnotics and SedativesMulticenter Studies as TopicNeoplasmsNorwayPiperazinesRandomized Controlled Trials as TopicSleepSleep Initiation and Maintenance DisordersTime FactorsTreatment OutcomeAzabicyclo CompoundsHypnotics and SedativesPiperazineszopicloneAdvanced cancerInsomniaPharmacological treatmentRandomized controlled trial

Identifiers

PMID30591073
PMCPMC6307135
OpenAlexW2906893837

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.