An observational study in Cancer and Opioid Induced Constipation (OIC), sponsored by Professor Monique A. H. Steegers. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Professor Monique A. H. Steegers · Observational
This study looks at how well a medicine called naldemedine works for people with cancer who become constipated while taking opioids. Opioids are medications prescribed to treat persistent or severe pain. Opioids can slow down the bowel and make it hard to pass stool. About 6 out of 10 people who use opioids have constipation. Laxatives such as lactulose or macrogol are described to help with this problem. If laxatives do not work, doctors may use special medicines called opioid blockers that act only in the gut. These medicines help relieve constipation without reducing pain relief. Naldemedine is one of these opioid blockers. It became available in the Netherlands in 2024 but is not yet widely used. The goal of this study is to learn how well naldemedine works in everyday care and how people feel while using it. Researchers will collect information on both medical results and participants' experiences.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 100 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Professor Monique A. H. Steegers as lead sponsor.
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Participants will be adults with cancer who are treated with opioids for pain managment. They will be recruited from multiple hospitals in the Netherlands. All participants will already be using laxatives to manage constipation. People who take part must be able to read Dutch and give written consent. Participants will represent a real-world group of individuals using opioids for cancer-related pain in daily clinical practice.
Exclusion Criteria:
Participants will be treated with naldemedine 0.2 milligrams orally once daily as monotherapy for a duration of 14 consecutive days, following discontinuation of laxatives, as intervention for opioid-induced constipation (OIC).
The change in Bowel Function Index (BFI) score
Bowel Function Index (BFI) is a brief, three-item questionnaire assessing opioid-induced constipation over the past 7 days. It measures ease of defecation, sensation of incomplete evacuation and personal judgment of constipation, each rated on a 0-100 numerical rating scale. Scores are averaged and recalculated to a 0-100 scale; a score ≥30 indicates clinically significant opioid-induced constipation.
Time frame: From enrollement to one week after initiation of naldemedine treatment
The change in Bowel Function Index (BFI) score
Time frame: From enrollment to two weeks after initiation of naldemedine
A clinically meaningful improvement in constipation
The proportion of patients achieving a ≥12-point decline in the Bowel Function Index (BFI) score.
Time frame: From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation.
The prevalence of persistent constipation, defined as a BFI score ≥ 30
Time frame: From enrollment to two weeks of treatment
The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores
The Patient Assessment of Constipation - Quality of Life (PAC-QoL) questionnaire is a 28-item questionnaire measuring the impact of constipation on daily functioning and well-being. Responses are given on a 5-point Likert scale, with higher scores indicating greater burden.
Time frame: From enrollment to two weeks of treatment with naldemedine
Continuation of naldemedine
Time frame: From enrollment to two weeks after initiation of naldemedine
Patient Satisfaction
Patient satisfaction is measured on an 11-point Likert scale (0 = "Not satisfied at all", 10 = "Very satisfied").
Time frame: From enrollment to two weeks of treatment with naldemedine
Patient likelihood to recommend the use of naldemedine to other patients
Net Promoter Score (NPS): Based on the question: "How likely are you to recommend naldemedine to another patient?" (0 = "Not likely at all", 10 = "Very likely"). NPS is calculated as the percentage of promoters (scores 9-10) minus detractors (scores 0-6), yielding a score between -100 and +100.
Time frame: From enrollment to two weeks of treatment with naldemedine
Plan to share: Undecided
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