Opioid-induced constipation in patients with advanced cancer, starting with opioids for pain MedDRA version: 24.0 Level: LLT Classification code 10071128 Term: Opioid induced constipation System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: MOVICOLON Naturel 13,7 g, poeder voor drank
Pharmaceutical Form: Oral powder in sachet
Trade Name: Magnesiumhydroxide Teva 724 mg, kauwtabletten
Pharmaceutical Form: Chewable tablet
Sponsors
ZonMw
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
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 • Maintenance treatment with laxatives during the last two weeks • Severely impaired renal function (serum creatinine >180 umol/l) • Estimated life expectancy <1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with advanced cancer, starting with opioids for pain: •To prove non-inferiority of magnesium hydroxide to macrogol/electrolytes in the prevention of OIC, based on the percentage of patients without obstipation (BFI-score <30) after 14 days of treatment ;Secondary Objective: In patients with advanced cancer, starting with opioids for pain: •To compare magnesium hydroxide with macrogol/electrolytes with regard to the Rome IV criteria after 14 days of treatment; •To compare magnesium hydroxide with macrogol/electrolytes with regard to quality of life (as measured with the EQ5D) after 14 days of treatment; •To compare magnesium hydroxide with macrogol/electrolytes with regard to side effects and patient satisfaction with laxative after 14 days of treatment; •To compare magnesium hydroxide with macrogol/electrolytes with regard to difference in pain score between laxative treatment after 14 days of treatment; •To compare magnesium hydroxide with macrogol/electrolytes with regard to comparative cost-effectiveness; •To predict non-resp[onders by gender, age, BMI, site of cancer, site of metastases and use of medication. ;Primary end point(s): The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index;Timepoint(s) of evaluation of this end point: On day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • Change of the Bowel Function Index Score between day 0 and day 14; • Quality of life; • Rome IV criteria for opioid-induced constipation as judged by professional care givers • Cancer pain score • Patient satisfaction with laxative; • Side effects of laxatives; • Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide. ;Timepoint(s) of evaluation of this end point: Secondary endpoints • Change of the Bowel Function Index Score between day 0 and day 14: day 0 and 14 • Quality of life: day 0 and 14 • Rome IV criteria for opioid-induced constipation as judged by professional care givers: day 0 and 14 • Cancer pain score: day 0 and 14 • Patient satisfaction with laxative: day 14 • Side effects of laxatives: day 14 • Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide: day 14 | — |
Countries
Netherlands
Contacts
Public ContactTrial Office
VU university medical center
Outcome results
None listed