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

Journal: BMC palliative care 2023;22(1):22

PMID: 36915062

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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 < 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 REGISTRATION

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

Address: Amsterdam UMC Location Vrije Universiteit Amsterdam, Medical Oncology, De Boelelaan 1117, Amsterdam, The Netherlands. [email protected].; Amsterdam UMC Location Vrije Universiteit Amsterdam, Anesthesiology, De Boelelaan 1117, Amsterdam, The Netherlands. [email protected].; Cancer Center Amsterdam, Treatment and Quality of Life, Amsterdam, The Netherlands. [email protected].; Department of Medical Oncology, University Medical Center Utrecht, Utrecht, Academic Hospice Demeter, De Bilt, The Netherlands.; Amsterdam UMC Location Vrije Universiteit Amsterdam, Clinical Pharmacology and Pharmacy, De Boelelaan 1117, Amsterdam, The Netherlands.; Spaarne Gasthuis Location Hoofddorp, Medical Oncology, Spaarnepoort 1, Hoofddorp, The Netherlands.; Department of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, The Netherlands.; Department of Epidemiology and Health Economics, University Medical Center Utrecht, Utrecht, The Netherlands.; Amsterdam UMC Location Vrije Universiteit Amsterdam, Medical Oncology, De Boelelaan 1117, Amsterdam, The Netherlands.; Cancer Center Amsterdam, Treatment and Quality of Life, Amsterdam, The Netherlands.; Amsterdam UMC Location Vrije Universiteit Amsterdam, Anesthesiology, De Boelelaan 1117, Amsterdam, The Netherlands.

DOI: 10.1186/s12904-023-01143-2

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MeSH Terms: Humans, Magnesium Hydroxide, Analgesics, Opioid, Laxatives, Constipation, Opioid-Induced Constipation, Quality of Life, Neoplasms, Polyethylene Glycols, Randomized Controlled Trials as Topic, Multicenter Studies as Topic