Evidence map›Paper›PMID 33087111›Full record

Trial reportBMC palliative care2020

Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial.

Peter G Lawlor, Marie T McNamara-Kilian, Alistair R MacDonald, Franco Momoli, Sallyanne Tierney, Nathalie Lacaze-Masmonteil, Monidipa Dasgupta, Meera Agar, Jose L Pereira, David C Currow and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC palliative care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02200172 (The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02200172 phase2completednot on this map

The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study Prior to a Larger Randomized Controlled Trial

TypeinterventionalSponsorBruyère Health Research Institute.Ran2014 to 2016Enrolled60ConditionsCancerArmsMelatonin, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Comparison of Two Doses of Prophylactic Melatonin on Incidence of Delirium in Intensive Care Unit Patients: A Randomized Controlled Trial.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2026
    Article
  6. Review
  7. Article
  8. Review
  9. The Dilemma of Treating Delirium: the Conundrum of Drug Management.Current treatment options in oncology · 2022
    Review
  10. 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

11 authors.

Peter G LawlorDivision of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada. plawlor@bruyere.org.ORCID http://orcid.org/0000-0001-7319-1395
Marie T McNamara-KilianBruyère Research Institute, Ottawa, Canada.
Alistair R MacDonaldBruyère Research Institute, Ottawa, Canada.
Franco MomoliSchool of Epidemiology and Public Health, University of Ottawa, London, Canada.
Sallyanne TierneyBruyère Continuing Care, Ottawa, Canada.
Nathalie Lacaze-MasmonteilOttawa Hospital Research Institute, Ottawa, Canada.
Monidipa DasguptaDepartment of Geriatric Medicine, Department of Medicine, University of Western Ontario, London, Canada.
Meera AgarCentre of Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Hamilton, Canada.
Jose L PereiraDivision of Palliative Care, Department of Family Medicine, McMaster University, Hamilton, Canada.
David C CurrowCentre of Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Hamilton, Canada.
Shirley H BushDivision of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDelirium is highly problematic in palliative care (PC). Preliminary data indicate a potential role for melatonin to prevent delirium, but no randomized controlled trials (RCTs) are reported in PC.

methodsPatients aged ≥18 years, with advanced cancer, admitted to an inpatient Palliative Care Unit (PCU), having a Palliative Performance Scale rating ≥ 30%, and for whom consent was obtained, were included in the study. Patients with delirium on admission were excluded. The main study objectives were to assess the feasibility issues of conducting a double-blind RCT of exogenous melatonin to prevent delirium in PC: recruitment, retention, procedural acceptability, appropriateness of outcome measures, and preliminary efficacy and safety data. Study participants were randomized in a double-blind, parallel designed study to receive daily melatonin 3 mg or placebo orally at 21:00 over 28 days or less if incident delirium, death, discharge or withdrawal occurred earlier. Delirium was diagnosed using the Confusion Assessment Method. Efficacy endpoints in the melatonin and placebo groups were compared using time-to-event analysis: days from study entry to onset of incident delirium.

resultsOver 16 months, 60/616 (9.7%; 95% CI: 7.5-12.4%) screened subjects were enrolled. The respective melatonin (n = 30) vs placebo (n = 30) outcomes were: incident delirium in 11/30 (36.7%; 95%CI: 19.9-56.1%) vs 10/30 (33%; 95% CI: 17.3-52.8%); early discharge (6 vs 5); withdrawal (6 vs 3); death (0 vs 1); and 7 (23%) vs 11 (37%) reached the 28-day end point. The 25th percentile time-to-event were 9 and 18 days (log rank, χ

conclusionsA larger double-blind RCT is feasible, but both subject accrual and withdrawal rates signal a need for multisite collaboration. The apparent trend for shorter time to incident delirium in the melatonin group bodes for careful monitoring in a larger trial.

trial registrationRegistered on July 21st 2014 with ClinicalTrials.gov : NCT02200172 .

Indexed as

AgedDeliriumDouble-Blind MethodFeasibility StudiesFemaleHumansMaleMelatoninMiddle AgedNeoplasmsOntarioPalliative CareMelatoninAdvanced cancerDeliriumFeasibility studyMelatoninPilotPreventionRandomized controlled trialSleep

Identifiers

PMID33087111
PMCPMC7579814

What OpenQuestion holds

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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.