Magnesium hydroxide versus macrogol/electrolytes in the prevention of opioid-induced constipation in incurable cancer patients

Autor: Kistemaker, K R J, de Graeff, Alexander, Crul, M, de Klerk, G, van de Ven, P M, van der Meulen, M P, van Zuylen, L, Steegers, M A H
Přispěvatelé: Internal medicine, Clinical pharmacology and pharmacy, Epidemiology and Data Science, Pediatrics, Anesthesiology, APH - Health Behaviors & Chronic Diseases, APH - Quality of Care, CCA - Cancer Treatment and quality of life
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Palliative Care, 22(1):22. BioMed Central
Kistemaker, K R J, de Graeff, A, Crul, M, de Klerk, G, van de Ven, P M, van der Meulen, M P, van Zuylen, L & Steegers, M A H 2023, ' 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) ', BMC Palliative Care, vol. 22, no. 1, 22, pp. 22 . https://doi.org/10.1186/s12904-023-01143-2
ISSN: 1472-684X
DOI: 10.1186/s12904-023-01143-2
Popis: 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 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 registration This trial is registered at clinicaltrials.gov: NCT05216328 and in the Dutch trial register: NTR80508. EudraCT number 2022–000408-36.
Databáze: OpenAIRE
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