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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): study protocol for an open-label, randomized controlled trial (the OMAMA study)

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Názov: 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): study protocol for an open-label, randomized controlled trial (the OMAMA study)
Autori: 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
Prispievatelia: MS Medische Oncologie, CTM & Statistical consultation, Cancer, HEE
Zdroj: BMC Palliat Care
BMC Palliative Care, Vol 22, Iss 1, Pp 1-8 (2023)
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
Informácie o vydavateľovi: Springer Science and Business Media LLC, 2023.
Rok vydania: 2023
Predmety: Magnesium Hydroxide, Macrogol/electrolytes, Constipation/chemically induced, Polyethylene Glycols/adverse effects, Laxatives/therapeutic use, Polyethylene Glycols, Magnesium hydroxide, Study Protocol, Neoplasms, Journal Article, Humans, Multicenter Studies as Topic, Neoplasms/complications, Cancer, Randomized Controlled Trials as Topic, Analgesics, Analgesics, Opioid/adverse effects, RC952-1245, General Medicine, 3. Good health, Clinical trial, Opioids, Analgesics, Opioid, Magnesium Hydroxide/adverse effects, Laxative, Special situations and conditions, Laxatives, Palliative care, Quality of Life, Opioid-Induced Constipation/drug therapy, Opioid/adverse effects, Constipation, Opioid-Induced Constipation
Popis: 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 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.DiscussionIn 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.
Druh dokumentu: Article
Other literature type
Popis súboru: application/pdf
Jazyk: English
ISSN: 1472-684X
DOI: 10.1186/s12904-023-01143-2
Prístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/36915062
https://doaj.org/article/de0de4c54a1b4e40af42b66a1e021371
https://research.vumc.nl/en/publications/9d888f6e-627f-42a0-a181-2d0b28022877
https://dspace.library.uu.nl/handle/1874/448809
https://pure.amsterdamumc.nl/en/publications/9943f27e-7056-4262-afeb-3e96c07593ba
https://doi.org/10.1186/s12904-023-01143-2
Rights: CC BY
Prístupové číslo: edsair.doi.dedup.....0312ee2b94a56d94fe6925f0b1fb5c31
Databáza: OpenAIRE
Popis
Abstrakt: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 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.DiscussionIn 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.
ISSN:1472684X
DOI:10.1186/s12904-023-01143-2