Clinical trial Recruiting at 13 sites Phase 4 Interventional Ages 18 and up

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment258 (estimated)
SponsorAmsterdam UMC, location VUmc
Academic / other
Locations13 sites (Almere Stad, Flevoland and 12 other locations)
StatusRecruiting
StartedDecember 2, 2022
Main results expectedJanuary 2027
Study endsJune 2027
Registry record updatedOctober 5, 2026
Trial IDNCT05216328 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.