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Which laxative best prevents constipation when cancer patients start opioids?

NCT ID NCT05216328

Prevention Sponsor: Amsterdam UMC, location VUmc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 05, 2026 · Last updated Oct 06, 2026 · Updated 1 time

Summary

Many people with advanced cancer take opioid pain medicines, which often cause constipation. This trial compares two laxatives, macrogol/electrolytes and magnesium hydroxide, to see which works better at preventing constipation when opioids are started. Adults with advanced cancer who are beginning slow-release or patch opioids join the study and are assigned by chance to one of the two laxatives. Researchers track bowel function, side effects, pain, and quality of life over two weeks to learn which option helps most.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
macrogol/electrolytes and magnesium hydroxide, two laxatives
What this could lead to
If one laxative works better or causes fewer side effects, doctors could have clearer guidance on which to prescribe first for people with advanced cancer who start opioids.
What could go wrong
This is a comparison of two existing laxatives, not a new drug, so the main question is which is more tolerable and effective. Results may show little difference, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cancer Pain neoplasm opioid-induced constipation prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation, opioid-induced

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC, location VUmc

    RECRUITING

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Flevoziekenhuis

    RECRUITING

    Almere Stad, Flevoland, 1315 RA, Netherlands

  • Groene Hart Hospital

    RECRUITING

    Gouda, South Holland, 2803 HH, Netherlands

  • Haaglanden Medical Centre

    RECRUITING

    The Hague, South Holland, 2512 VA, Netherlands

  • Jeroen Bosch Ziekenhuis

    RECRUITING

    's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Martini Hospital Groningen

    RECRUITING

    Groningen, Provincie Groningen, 9728 NT, Netherlands

  • Radboud university Medical center Nijmegen

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rijnstate Ziekenhuis

    RECRUITING

    Arnhem, Gelderland, 6815 AD, Netherlands

  • Spaarne Gasthuis

    RECRUITING

    Hoofddorp, North Holland, 2134 TM, Netherlands

  • University Medical Center Groningen

    RECRUITING

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

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