Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Prävention von Opioid-induzierter Verstopfung bei Patienten mit metastasierendem Krebs (OMAMA)

30. September 2026 aktualisiert von: Lia van Zuylen, Amsterdam UMC, location VUmc

OMAMA-Studie – Prävention von Opioid-induzierter Obstipation bei Patienten mit metastasierendem Krebs

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

258

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Arzneimittel: Macrogol Only Product in Oral Dose Form

Information already included in arm/group description.

Andere Namen:
  • Macrogol/Elektrolyte
Aktiver 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.
Arzneimittel: Magnesium hydroxide 724mg

Information already included in arm/group description.

Andere Namen:
  • Magnesiumoxid

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The percentage of patients with a score of <30 of the Bowel Function Index
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The EQ5D
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: On day 0 and day 14

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Amsterdam UMC, location VUmc

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Dezember 2022

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

19. Januar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Januar 2022

Zuerst gepostet (Tatsächlich)

31. Januar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 08440012010002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren