Prevention of Opioid-induced Constipation in Patients With Metastatic Cancer
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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 they used after the study through regular
prescription.
We 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, we 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.
Phase:
Phase 3
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
Erasmus Medical Center Flevoziekenhuis Jeroen Bosch Ziekenhuis Leiden University Medical Center Radboud Ziekenhuis Spaarne Gasthuis UMC Utrecht University Medical Center Groningen Ziekenhuis Rijnstate