Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05216328

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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Prevention of Opioid-induced Constipation in Patients With Advanced Cancer | DecenTrialz