Actively Recruiting
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Led by Amsterdam UMC, location VUmc · Updated on 2024-11-22
330
Participants Needed
13
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic cancer aged 18 years or older
- Starting slow release or transdermal opioids for pain
- Able to complete a Dutch questionnaire
- Previous opioid treatment allowed if stopped more than 4 weeks ago
You will not qualify if you...
- Contraindications for laxatives
- Use of laxatives in the last 4 weeks
- Severely impaired renal function (serum creatinine >180 umol/l)
- Estimated life expectancy less than 3 months
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands, 1315 RA
Actively Recruiting
2
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands, 6815 AD
Actively Recruiting
3
Radboud university Medical center Nijmegen
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
4
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
Actively Recruiting
5
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
6
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2134 TM
Actively Recruiting
7
Groene Hart Hospital
Gouda, South Holland, Netherlands, 2803 HH
Actively Recruiting
8
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
9
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
10
Haaglanden Medical Centre
The Hague, South Holland, Netherlands, 2512 VA
Actively Recruiting
11
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
12
Martini Hospital Groningen
Groningen, Netherlands, 9728 NT
Actively Recruiting
13
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
K
Kay Kistemaker, MSc/MD
CONTACT
L
Lia van Zuylen, Prof. dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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