Status:
RECRUITING
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Leiden University Medical Center
University Medical Center Groningen
Conditions:
Constipation, Opioid-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. ...
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 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
Exclusion
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05216328
Start Date
December 2 2022
End Date
December 1 2025
Last Update
November 22 2024
Active Locations (13)
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1
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands, 1315 RA
2
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands, 6815 AD
3
Radboud university Medical center Nijmegen
Nijmegen, Gelderland, Netherlands, 6525 GA
4
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ