Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
NCT ID: NCT05216328
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
330 participants
INTERVENTIONAL
2022-12-02
2025-12-31
Brief Summary
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The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription.
The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Macrogol/electrolytes
Macrogol/electrolytes is started at a dose of 1 sachet once a day orally, based on the current guideline 'Diagnosis and treatment of pain in patients with cancer' (www.pallialine.nl). The dose of macrogol/electrolytes may be increased to 2 sachets a day during the study period.
The effect of laxatives will be judged after 14 days.
Macrogol Only Product in Oral Dose Form
Information already included in arm/group description.
Magnesium hydroxide
Magnesium hydroxide is started at a dose of 724 mg three times a day orally, based on the current guideline 'Diagnosis and treatment of pain in patients with cancer' (www.pallialine.nl). The dose of magnesium hydroxide may be increased to 1448 mg three times a day during the study period. The effect of laxatives will be judged after 14 days.
Magnesium hydroxide 724mg
Information already included in arm/group description.
Interventions
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Macrogol Only Product in Oral Dose Form
Information already included in arm/group description.
Magnesium hydroxide 724mg
Information already included in arm/group description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic cancer (≥18 years);
* Starting with slow release or transdermal opioids for pain;
* Able to complete a Dutch questionnaire. Previous treatment with opioids is allowed, if discontinued more than 4 weeks ago.
Exclusion Criteria
* Patients with contra-indications for laxatives
* Use of laxatives during the last four weeks
* Severely impaired renal function (serum creatinine \>180 umol/l)
* Estimated life expectancy \<3 months
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Erasmus Medical Center
OTHER
Spaarne Gasthuis
OTHER
Rijnstate Hospital
OTHER
Jeroen Bosch Ziekenhuis
OTHER
Flevoziekenhuis
OTHER
Martini Hospital Groningen
OTHER
Haaglanden Medical Centre
OTHER
UMC Utrecht
OTHER
Groene Hart Ziekenhuis
OTHER
Bernhoven Hospital
OTHER
Isala
OTHER
Antoni van Leeuwenhoekziekenhuis (AVL) Amsterdam
UNKNOWN
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Lia van Zuylen
Prof. Dr.
Principal Investigators
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Lia van Zuylen, Prof.dr.
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands
Radboud university Medical center Nijmegen
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Groene Hart Hospital
Gouda, South Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haaglanden Medical Centre
The Hague, South Holland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Martini Hospital Groningen
Groningen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Abramowitz L, Beziaud N, Causse C, Chuberre B, Allaert FA, Perrot S. Further validation of the psychometric properties of the Bowel Function Index for evaluating opioid-induced constipation (OIC). J Med Econ. 2013 Dec;16(12):1434-41. doi: 10.3111/13696998.2013.851083. Epub 2013 Oct 24.
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Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
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Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.
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Freedman MD, Schwartz HJ, Roby R, Fleisher S. Tolerance and efficacy of polyethylene glycol 3350/electrolyte solution versus lactulose in relieving opiate induced constipation: a double-blinded placebo-controlled trial. J Clin Pharmacol. 1997 Oct;37(10):904-7. doi: 10.1002/j.1552-4604.1997.tb04264.x.
Ginex PK, Hanson BJ, LeFebvre KB, Lin Y, Moriarty KA, Maloney C, Vrabel M, Morgan RL. Management of Opioid-Induced and Non-Opioid-Related Constipation in Patients With Cancer: Systematic Review and Meta-Analysis. Oncol Nurs Forum. 2020 Nov 1;47(6):E211-E224. doi: 10.1188/20.ONF.E211-E224.
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Related Links
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guidelines palliative care
The Dutch digital palliative care platform
Other Identifiers
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08440012010002
Identifier Type: -
Identifier Source: org_study_id
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