Prevention of Opioid-induced Constipation in Patients With Advanced Cancer (OMAMA)
Constipation, Opioid-Induced
About this trial
This is an interventional prevention trial for Constipation, Opioid-Induced focused on measuring Cancer, Palliative care, Cancer pain, Opioid-Induced Constipation, macrogol/electrolytes, magnesium hydroxide
Eligibility Criteria
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
Sites / Locations
- FlevoziekenhuisRecruiting
- Rijnstate ZiekenhuisRecruiting
- Radboud university Medical center NijmegenRecruiting
- Jeroen Bosch ZiekenhuisRecruiting
- Amsterdam UMC, location VUmcRecruiting
- Spaarne GasthuisRecruiting
- Groene Hart Hospital
- Haaglanden Medical Centre
- Leiden University Medical CenterRecruiting
- Erasmus Medical CenterRecruiting
- University Medical Center GroningenRecruiting
- Martini Hospital GroningenRecruiting
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Macrogol/electrolytes
Magnesium hydroxide
Macrogol/electrolytes is started at a dose of 1 sachet once a day orally, based on the current guideline 'Diagnosis and treatment of pain in patients with cancer' (www.pallialine.nl). The dose of macrogol/electrolytes may be increased to 2 sachets a day during the study period. The effect of laxatives will be judged after 14 days.
Magnesium hydroxide is started at a dose of 724 mg three times a day orally, based on the current guideline 'Diagnosis and treatment of pain in patients with cancer' (www.pallialine.nl). The dose of magnesium hydroxide may be increased to 1448 mg three times a day during the study period. The effect of laxatives will be judged after 14 days.