Preventing constipation caused by opioids in advanced cancer patients
Official title: OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Run by Amsterdam UMC, location VUmc · NCT05216328 · Data updated 2026-11-12
This study is testing whether magnesium hydroxide can help prevent constipation caused by opioid pain medications in advanced cancer patients better than a standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 258 (estimated) |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 13 sites (Almere Stad, Flevoland and 12 other locations) |
| Status | Recruiting |
| Started | December 2, 2022 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT05216328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with metastatic cancer who are beginning treatment with slow-release or transdermal opioids.
✕Probably not a fit
Patients with contraindications for laxatives, those using laxatives in the past four weeks, or those with severely impaired renal function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of magnesium hydroxide compared to macrogol/electrolytes in preventing opioid-induced constipation (OIC) in patients with advanced cancer who are starting opioid treatment for pain management. Given that OIC affects a significant portion of cancer patients, the study will assess the tolerability and efficacy of these treatments in improving patient quality of life. Participants will be required to complete a questionnaire in Dutch to assess their symptoms and treatment outcomes. The study is designed to provide insights into a less commonly used laxative option that may be more acceptable to patients due to its neutral taste.
Why it matters
Potential benefit: If successful, this study could provide a more tolerable treatment option for preventing constipation in patients undergoing opioid therapy for cancer pain.
How similar studies have gone: While macrogol/electrolytes has been proven effective for OIC, magnesium hydroxide has not been extensively studied for this purpose, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Patients with advanced 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients with contra-indications for laxatives * Maintenance treatment with laxatives during the last 14 days * Severely impaired renal function (serum creatinine \>180 umol/l) * Estimated life expectancy \<1 month
Where it's running
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Flevoziekenhuis
Almere Stad, Flevoland, Netherlands Recruiting -
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands Recruiting -
Radboud university Medical center Nijmegen
Nijmegen, Gelderland, Netherlands Recruiting -
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands Recruiting -
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands Recruiting -
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands Recruiting
Show 7 more locations
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University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands Recruiting -
Martini Hospital Groningen
Groningen, Provincie Groningen, Netherlands Recruiting -
Groene Hart Hospital
Gouda, South Holland, Netherlands Recruiting -
Leiden University Medical Center
Leiden, South Holland, Netherlands Recruiting -
Erasmus Medical Center
Rotterdam, South Holland, Netherlands Recruiting -
Haaglanden Medical Centre
The Hague, South Holland, Netherlands Recruiting -
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Lia van Zuylen, Prof.dr. — Amsterdam UMC, location VUmc
- Study coordinator: Kay Kistemaker, MSc/MD
- Email: k.kistemaker@amsterdamumc.nl
- Phone: +31 6 50087799
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.