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Forebyggelse af opioid-induceret obstipation hos patienter med metastatisk kræft (OMAMA)

30. september 2026 opdateret af: Lia van Zuylen, Amsterdam UMC, location VUmc

OMAMA-undersøgelse - Forebyggelse af opioid-induceret obstipation hos patienter med metastatisk kræft

More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline "Diagnosis and treatment of pain in patients with cancer" it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

258

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Holland
    • Flevoland
    • Gelderland
      • Arnhem, Gelderland, Holland, 6815 AD
      • Nijmegen, Gelderland, Holland, 6525 GA
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Holland, 5223 GZ
        • Rekruttering
        • Jeroen Bosch Ziekenhuis
        • Kontakt:
    • North Holland
      • Amsterdam, North Holland, Holland, 1081 HV
        • Rekruttering
        • Amsterdam UMC, location VUmc
        • Kontakt:
      • Hoofddorp, North Holland, Holland, 2134 TM
    • Provincie Groningen
      • Groningen, Provincie Groningen, Holland, 9713 GZ
        • Rekruttering
        • University Medical Center Groningen
        • Kontakt:
      • Groningen, Provincie Groningen, Holland, 9728 NT
        • Rekruttering
        • Martini Hospital Groningen
        • Kontakt:
    • South Holland
      • Gouda, South Holland, Holland, 2803 HH
        • Rekruttering
        • Groene Hart Hospital
        • Kontakt:
      • Leiden, South Holland, Holland, 2333 ZA
        • Rekruttering
        • Leiden University Medical Center
        • Kontakt:
      • Rotterdam, South Holland, Holland, 3015 GD
      • The Hague, South Holland, Holland, 2512 VA
    • Utrecht
      • Utrecht, Utrecht, Holland, 3584 CX

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: Macrogol Only Product in Oral Dose Form

Information already included in arm/group description.

Andre navne:
  • Makrogol/elektrolytter
Aktiv komparator: 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.
Medicin: Magnesium hydroxide 724mg

Information already included in arm/group description.

Andre navne:
  • Magnesiumoxid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The percentage of patients with a score of <30 of the Bowel Function Index
Tidsramme: On day 14

A clinician-administered patient-reported questionnaire to assess clinically significant constipation, validated in patients receiving opioids for chronic non-malignant pain and for malignant pain (Abramovitz 2013, Rentz 2009 and 2011). It consists of three questions, assessing ease of defecation, feeling of incomplete bowel evacuation and personal judgement of the patient regarding constipation, each during the last 7 days and each rated on a scale of 0 (best possible outcome) to 100 (worst possible outcome). A total score ≥30 (mean of the three separate scores) indicates clinically significant constipation. A change of the total score of >12 is regarded as clinically meaningful. It has been used in a large observational study in cancer patients receiving opioids (Davies 2021) and in randomised trials of opioid antagonists for OIC (Ahmedzai 2012, Dupoiron 2017, Leng 2020, Poelaert 2015). It has been recommended as the assessment tool of choice for OIC (Argoff 2015, Farmer 2019).
On day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The EQ5D
Tidsramme: On day 0 and day 14

A self-administered, generic assessment tool developed by the EuroQol Group, a network of international research teams, and consists of questions on five dimensions of health (i.e., mobility, self-care, pain/discomfort, usual activities, and anxiety/depression) (Pickard 2007). It has been used in cost-effectiveness studies on OIC (Dunlop 2012, Hjalte 2016, Lawson 2016).
On day 0 and day 14
Rome IV criteria for opioid-induced constipation
Tidsramme: On day 0 and day 14

Rome IV criteria for opioid-induced constipation as judged by professional care givers (Davies 2021, Drossman 2016), including:

  • straining during >25% of defecations
  • lumpy or hard stools in >25% of defecations
  • sensation of incomplete evacuation in >25% of defecations
  • sensation of anorectal obstruction/blockage in >25% of defecations
  • manual manoeuvres to facilitate >25% of defecations
  • <3 spontaneous defecations per week At least two of these criteria have to be fulfilled in order to diagnose constipation, to be judged by the treating physician or clinical nurse specialists/nurse practitioners
On day 0 and day 14
Cancer pain score
Tidsramme: On day 0 and day 14

Numeric Rating SDcale, ranging from 0 to 10
On day 0 and day 14
Patient satisfaction with laxative
Tidsramme: On day 14

A single four-item question, ranging from unsatisfied to very satisfied.
On day 14
Side effects of laxatives
Tidsramme: On day 14

All side-effects are scored on a four-point Likert scale (not at all, a bit, rather, very much):

  • Bad taste
  • Problems with swallowing
  • Abdominal cramps
  • Nausea
  • Flatulence
  • Diarrhea
  • Other (to be specified by the patient)
On day 14
Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide
Tidsramme: On day 14

We aim to perform a comparative cost-effectiveness of the laxatives. This requires data collection on healthcare procedures and QOL in responders, non-responders and patients with side-effects of laxatives for the follow-up period of the study. These healthcare procedures will be extracted from hospital databases and healthcare use outside the hospital will be collected with the iMCQ at 4 weeks. All individual health care procedures will be linked to their unit costs. Reimbursement prices issued by the Dutch Healthcare Authority and national reference prices will be used for this assessment as outlined in current Dutch pharmaco-economic guidance. The cost-effectiveness analysis will be performed using a decision tree including different branches for initial therapy and responders and non-responders. The costs and QOL of the patients in the trial will be used as input for this decision tree. Total costs and effects will be calculated by summing the costs and effects of each branch.
On day 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amsterdam UMC, location VUmc

Samarbejdspartnere

Radboud University Medical Center
University Medical Center Groningen
UMC Utrecht
Erasmus Medical Center
Leiden University Medical Center
Rijnstate Hospital
Groene Hart Ziekenhuis
Flevoziekenhuis
Spaarne Gasthuis
Jeroen Bosch Ziekenhuis
Isala
Martini Hospital Groningen
Bernhoven Hospital
Haaglanden Medical Centre
Antoni van Leeuwenhoek Hospital

Efterforskere

  • Ledende efterforsker: Lia van Zuylen, Prof.dr., Amsterdam UMC, location VUmc

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. december 2022

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

19. januar 2022

Først indsendt, der opfyldte QC-kriterier

19. januar 2022

Først opslået (Faktiske)

31. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08440012010002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Due to the sensitivity of the data, the underlying data sets will not be shared publicly but will be made available for verification/ inspection purposes. Additional sharing conditions will be considered (e.g. via the Personal Health Train initiative from Health-RI, which is currently under development) while respecting the type of informed consent provided by the subjects and discussed with the support of Legal/Privacy/RDM experts where appropriate. For descriptive documentation (protocol, data dictionary, syntax/script, etc.) the study team will collaborate with RDM, to ensure such data can be found and made available to other researchers. Providing information in an online (metadata) catalogue that is certified holds preference.

We are considering using a DANS repository or similar. DANS EASY is commonly used, uses the Dublin Core Metadata standard, provides a PID and holds a Core Trust Seal. However, DANS is initiatiating Data Stations, with a specific one for the Life Sciences and

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