Evidence map›Paper›PMID 26260726›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

The effect of melatonin on sleep and quality of life in patients with advanced breast cancer.

Pasquale F Innominato, Andrew S Lim, Oxana Palesh, Mark Clemons, Maureen Trudeau, Andrea Eisen, Cathy Wang, Alex Kiss, Kathleen I Pritchard, Georg A Bjarnason

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04287543 (Effect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's Disease), which is not on this map. Cited by 74 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 6 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT04287543 phase2 / phase3withdrawnnot on this mapstarted 2021, after this paper: background citation

Effect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's Disease

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2021 to 2022Enrolled0ConditionsParkinson DiseaseArmsMelatonin, Placebos
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 6 syntheses or guidelines pooled it, 106 citations in OpenAlex.

  1. Pooled it
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  4. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5).Annals of oncology : official journal of the European Society for Medical Oncology · 2020
    Guideline
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14 more citing papers are in PubMed but not listed here.

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 6 institutions in 4 countries.

Pasquale F InnominatoINSERM and Paris South University UMR-S0776, Biological Rhythms and Cancers and APHP, Chronotherapy Unit, Department of Oncology, Paul Brousse Hospital, 12-14 Avenue Paul Vaillant Couturier, 94800, Villejuif, France.
Andrew S LimDivision of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Oxana PaleshDepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, 94305-5717, USA.
Mark ClemonsDivision of Medical Oncology, The Ottawa Hospital Cancer Centre, Department of Medicine, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
Maureen TrudeauDivision of Medical Oncology, Sunnybrook Odette Cancer Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Andrea EisenDivision of Medical Oncology, Sunnybrook Odette Cancer Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Cathy WangDivision of Medical Oncology, Sunnybrook Odette Cancer Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Alex KissDepartment of Research Design and Biostatistics, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Kathleen I PritchardDivision of Medical Oncology, Sunnybrook Odette Cancer Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada.
Georg A BjarnasonDivision of Medical Oncology, Sunnybrook Odette Cancer Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. georg.bjarnason@sunnybrook.ca.
Sunnybrook Health Science Centre · CAAssistance Publique – Hôpitaux de Paris · FRHealth Sciences Centre · CAOttawa Hospital · CAStanford University · USUniversity of Toronto · CA

Funding

Management of Insomnia in Cancer PatientsK07CA132916 · NCI · UNIVERSITY OF ROCHESTER · PI PALESH, OXANA G · 2008 to 2012
$679k
Canadian Institutes of Health Research OOG MOP125934NCI NIH HHS K07CA132916
6 · The paper itself

Abstract

backgroundFatigue and sleep problems are prevalent in cancer patients and can be associated with disruption of circadian rhythmicity. In this prospective phase II trial, we sought to assess the effect of melatonin on circadian biomarkers, sleep, and quality of life in breast cancer patients.

methodsThirty-two patients with metastatic breast cancer, receiving hormonal or trastuzumab therapy, took 5 mg of melatonin at bedtime for 2 months. Before starting and after 2 months on melatonin therapy, sleep and circadian rhythmicity were assessed by actigraphy, diurnal patterns of serum cortisol, and the expression of the core clock genes PER2 and BMAL1 in peripheral blood mononuclear cells. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire was completed for subjective parameters.

resultsBedtime melatonin was associated with a significant improvement in a marker of objective sleep quality, sleep fragmentation and quantity, subjective sleep, fatigue severity, global quality of life, and social and cognitive functioning scales. Morning clock gene expression was increased following bedtime melatonin intake. Melatonin did not affect actigraphy measure of circadian rhythmicity, or the diurnal cortisol pattern.

conclusionThese results invite further investigation of melatonin as a potentially useful therapeutic agent for improving sleep and quality of life in cancer patients.

Indexed as

ActigraphyAdultAgedBreast NeoplasmsCentral Nervous System DepressantsFatigueFemaleHumansMelatoninMiddle AgedProspective StudiesQuality of LifeSleepCentral Nervous System DepressantsMelatoninActigraphyBreast cancerCircadianClock genesMelatoninQuality of lifeSleep

Identifiers

PMID26260726
OpenAlexW1172612535

What OpenQuestion holds

Textmetadata
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.