التفاصيل البيبلوغرافية
| العنوان: |
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) |
| المؤلفون: |
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. |
| المساهمون: |
MS Medische Oncologie, CTM & Statistical consultation, Cancer, HEE |
| سنة النشر: |
2023 |
| مصطلحات موضوعية: |
Analgesics, Opioid/adverse effects, Constipation/chemically induced, Humans, Laxatives/therapeutic use, Magnesium Hydroxide/adverse effects, Multicenter Studies as Topic, Neoplasms/complications, Opioid-Induced Constipation/drug therapy, Polyethylene Glycols/adverse effects, Quality of Life, Randomized Controlled Trials as Topic, Laxative, Macrogol/electrolytes, Opioids, Palliative care, Clinical trial, Magnesium hydroxide, Constipation, Cancer, General Medicine, Journal Article |
| الوصف: |
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. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| تدمد: |
1472-684X |
| Relation: |
https://dspace.library.uu.nl/handle/1874/448809 |
| الاتاحة: |
https://dspace.library.uu.nl/handle/1874/448809 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: |
edsbas.7EB20B51 |
| قاعدة البيانات: |
BASE |
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