Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

Last updated: November 19, 2024
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

4

Condition

Constipation

Treatment

Macrogol Only Product in Oral Dose Form

Magnesium hydroxide 724mg

Clinical Study ID

NCT05216328
08440012010002
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Patients with metastatic 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

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

  • Use of laxatives during the last four weeks

  • Severely impaired renal function (serum creatinine >180 umol/l)

  • Estimated life expectancy <3 months

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Macrogol Only Product in Oral Dose Form
Phase: 4
Study Start date:
December 02, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Flevoziekenhuis

    Almere, Flevoland 1315 RA
    Netherlands

    Active - Recruiting

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland 6815 AD
    Netherlands

    Active - Recruiting

  • Radboud university Medical center Nijmegen

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Jeroen Bosch Ziekenhuis

    's Hertogenbosch, Noord-Brabant 5223 GZ
    Netherlands

    Active - Recruiting

  • Amsterdam UMC, location VUmc

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Active - Recruiting

  • Spaarne Gasthuis

    Hoofddorp, Noord-Holland 2134 TM
    Netherlands

    Active - Recruiting

  • Groene Hart Hospital

    Gouda, South Holland 2803 HH
    Netherlands

    Active - Recruiting

  • Haaglanden Medical Centre

    The Hague, South Holland 2512 VA
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, Zuid-Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Active - Recruiting

  • Martini Hospital Groningen

    Groningen, 9728 NT
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

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