Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

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.

Conditions

• Constipation, Opioid-Induced

Interventions

DRUG

Macrogol Only Product in Oral Dose Form

Information already included in arm/group description.

DRUG

Magnesium hydroxide 724mg

Information already included in arm/group description.

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Flevoziekenhuis

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Haaglanden Medical Centre

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Groene Hart Ziekenhuis

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Isala

  collaborator OTHER

• Antoni van Leeuwenhoekziekenhuis (AVL) Amsterdam

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-02

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Netherlands

Study Locations