*Prevention of opioid-induced constipation in patients with advanced cancer*
Phase 4
Recruiting
- Conditions
- constipation10018012
- Registration Number
- NL-OMON53756
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 330
Inclusion Criteria
• Patients with advanced 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
• Patients with contra-indications for laxatives • Maintenance treatment with
laxatives during the last two weeks • Severely impaired renal function (serum
creatinine >180 umol/l) • Estimated life expectancy <1 month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is constipation, defined as the percentage of patients<br /><br>with a score of <30 of the Bowel Function Index, measured on day 14.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Change of the Bowel Function Index Score between day 0 and day 14;<br /><br>• Quality of life;<br /><br>• Rome IV criteria for opioid-induced constipation as judged by professional<br /><br>care givers<br /><br>• Cancer pain score<br /><br>• Patient satisfaction with laxative;<br /><br>• Side effects of laxatives;<br /><br>• Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide</p><br>