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.
Adult (≥18 years)
A diagnosis of malignancy
Daily use of opioids
Use of laxatives
Use of other opioid antagonists in the last month
Suspected (risk of) gastrointestinal perforation
Participation in another study that may confound the results of this trial
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.
Cohort
Prospective
Naldemedine, an peripherally acting opioid antagonist
DrugParticipants 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.
The change in Bowel Function Index (BFI) score
A clinically meaningful improvement in constipation
The proportion of patients achieving a ≥12-point decline in the Bowel Function Index (BFI) score.
The prevalence of persistent constipation, defined as a BFI score ≥ 30
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.
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Professor Monique A. H. Steegers
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
Viatris Inc.
Collaborator
