Evidence map›Paper›PMID 36915062›Full record

ArticleBMC palliative care2023

Magnesium hydroxide versus macrogol/electrolytes in the prevention of opioid-induced constipation in incurable cancer patients: study protocol for an open-label, randomized controlled trial (the OMAMA study).

K R J Kistemaker, A de Graeff, M Crul, G de Klerk, P M van de Ven, M P van der Meulen, L van Zuylen, M A H Steegers

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

Article in BMC palliative care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05216328 (OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT05216328 phase4recruitingnot on this map

OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2022 to 2025Enrolled330ConditionsConstipation, Opioid-InducedArmsMacrogol Only Product in Oral Dose Form, Magnesium hydroxide 724mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 4 institutions in 1 country.

K R J KistemakerAmsterdam UMC Location Vrije Universiteit Amsterdam, Medical Oncology, De Boelelaan 1117, Amsterdam, The Netherlands. k.kistemaker@amsterdamumc.nl.
A de GraeffDepartment of Medical Oncology, University Medical Center Utrecht, Utrecht, Academic Hospice Demeter, De Bilt, The Netherlands.
M CrulAmsterdam UMC Location Vrije Universiteit Amsterdam, Clinical Pharmacology and Pharmacy, De Boelelaan 1117, Amsterdam, The Netherlands.
G de KlerkSpaarne Gasthuis Location Hoofddorp, Medical Oncology, Spaarnepoort 1, Hoofddorp, The Netherlands.
P M van de VenDepartment of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands.
M P van der MeulenDepartment of Epidemiology and Health Economics, University Medical Center Utrecht, Utrecht, The Netherlands.
L van Zuylen *Amsterdam UMC Location Vrije Universiteit Amsterdam, Medical Oncology, De Boelelaan 1117, Amsterdam, The Netherlands.
M A H Steegers *Amsterdam UMC Location Vrije Universiteit Amsterdam, Anesthesiology, De Boelelaan 1117, Amsterdam, The Netherlands.
University Medical Center Utrecht · NLAmsterdam University Medical Centers · NLVrije Universiteit Amsterdam · NLSpaarne Gasthuis · NL

Funding

ZonMw 08440012010002
6 · The paper itself

Abstract

backgroundOpioid-induced constipation (OIC) is a common symptom in cancer patients treated with opioids with a prevalence of up to 59%. International guidelines recommend standard laxatives such as macrogol/electrolytes and magnesium hydroxide to prevent OIC, although evidence from randomized controlled trials is largely lacking. The aim of our study is to compare magnesium hydroxide with macrogol /electrolytes in the prevention of OIC in patients with incurable cancer and to compare side-effects, tolerability and cost-effectiveness.

methodsOur study is an open-label, randomized, multicenter study to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. In total, 330 patients with incurable cancer, starting with opioids for pain management, will be randomized to treatment with either macrogol/electrolytes or magnesium hydroxide. The primary outcome measure is the proportion of patients with a score of < 30 on the Bowel Function Index (BFI), measured on day 14. The Rome IV criteria for constipation, side effects of and satisfaction with laxatives, pain scores, quality of life (using the EQ-5D-5L), daily use of laxatives and escape medication, and cost-effectiveness will also be assessed. DISCUSSION: In this study we aim to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. The outcome of our study will contribute to prevention of OIC and scientific evidence of guidelines on (opioid-induced) constipation.

trial registrationThis trial is registered at clinicaltrials.gov: NCT05216328 and in the Dutch trial register: NTR80508. EudraCT number 2022-000408-36.

Indexed as

NeoplasmsOpioid-Induced ConstipationAnalgesics, OpioidConstipationHumansLaxativesMagnesium HydroxideMulticenter Studies as TopicPolyethylene GlycolsQuality of LifeRandomized Controlled Trials as TopicAnalgesics, OpioidLaxativesMagnesium HydroxidePolyethylene GlycolsCancerClinical trialConstipationLaxativeMacrogol/electrolytesMagnesium hydroxideOpioidsPalliative care

Identifiers

PMID36915062
PMCPMC10012532
OpenAlexW4324128629

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read34
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.