Evidence map›Paper›PMID 27515515›Full record

Trial reportTrials2016

The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial.

Shirley Harvey Bush, Nathalie Lacaze-Masmonteil, Marie Theresa McNamara-Kilian, Alistair Richard MacDonald, Sallyanne Tierney, Franco Momoli, Meera Agar, David Christopher Currow, Peter Gerard Lawlor

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

Trial report in Trials, 2016. 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 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 13% 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.

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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Melatonin in cancer treatment.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Promising Antineoplastic Actions of Melatonin.Frontiers in pharmacology · 2018
    Review
  7. Article
  8. Article
  9. Review
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

9 authors at 5 institutions in 2 countries.

Shirley Harvey BushDivision of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada. sbush@bruyere.org.
Nathalie Lacaze-MasmonteilOttawa Hospital Research Institute (OHRI), 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
Marie Theresa McNamara-KilianBruyère Research Institute (BRI), 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.
Alistair Richard MacDonaldBruyère Research Institute (BRI), 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.
Sallyanne TierneyBruyère Continuing Care, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.
Franco MomoliOttawa Hospital Research Institute (OHRI), 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
Meera AgarCentre of Cardiovascular and Chronic Care, Faculty of Health, University of Technology Sydney, Level 3, 235 Jones Street, Ultimo, NSW, 2007, Australia.
David Christopher CurrowDiscipline, Palliative and Supportive Services, Bedford Park, Flinders University, Adelaide, SA, Australia.
Peter Gerard LawlorDivision of Palliative Care, Department of Medicine, University of Ottawa, 43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada.
Bruyère · CAFlinders University · AUOttawa Hospital · CAOttawa Hospital Research InstituteUniversity of Technology Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDelirium is a very common and distressing neuropsychiatric syndrome in palliative care. Increasing age, the presence of dementia and advanced cancer are well-known predisposing risk factors for delirium development. Sleep-wake cycle disturbance is frequently seen during delirium and melatonin has a pivotal role in the regulation of circadian rhythms. Current evidence across various settings suggests a potential preventative role for melatonin in patients at risk of delirium, but no studies are currently reported in patients with advanced cancer. The aim of this article is to describe the design of a feasibility study that is being conducted to inform a larger randomized, placebo-controlled, double-blind trial (RCT) to evaluate the role of exogenously administered melatonin in preventing delirium in patients with advanced cancer. METHODS/

designAdult patients with a cancer diagnosis who are admitted to the palliative care unit will be randomized into a treatment or placebo group. The pharmacological intervention consists of a single daily dose of immediate-release melatonin (3 mg) at 21:00 ± 1 h, from day 1 to day 28 of admission. The primary objective of this initial study is to assess the feasibility of conducting the proposed RCT by testing recruitment and retention rates, appropriateness of study outcome measures, acceptability of study procedures and effectiveness of the blinding process. The primary outcome measure of the proposed larger RCT is time to first inpatient incident episode of delirium. We also plan to collect data on incident rates of delirium and patient-days of delirium, adjusting for length of admission. DISCUSSION: The outcomes of this feasibility study will provide information on recruitment and retention rates, protocol violation frequency, effectiveness of the blinding process, acceptability of the study procedures, and safety of the proposed intervention. This will inform the design of a fully powered randomized controlled trial to evaluate the preventative role of melatonin administration in patients with advanced cancer.

trial registrationRegistered with ClinicalTrials.gov: NCT02200172 Registered on 21 July 2014. Health Canada protocol number: BRI-MELAT-2013 (Final approved protocol version (Version 3): 18 June 2014) (Notice of Amended Authorization (NOA) received 14 November 2014).

Indexed as

Palliative CareCentral Nervous System AgentsClinical ProtocolsDementiaDouble-Blind MethodFeasibility StudiesHumansMelatoninNeoplasmsOntarioResearch DesignRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeCentral Nervous System AgentsMelatoninAdvanced cancerDeliriumFeasibility studyMelatoninPilotPreventionRandomized controlled trial (RCT)Sleep

Identifiers

PMID27515515
PMCPMC4982224
OpenAlexW2512129242

What OpenQuestion holds

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LicenceCC BY
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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.