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)

Autor: 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
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Palliative Care, Vol 22, Iss 1, Pp 1-8 (2023)
Druh dokumentu: article
ISSN: 1472-684X
DOI: 10.1186/s12904-023-01143-2
Popis: Abstract Background Opioid-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. Methods Our 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
Databáze: Directory of Open Access Journals
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