Cancer, Opioid Induced Constipation (OIC)
Conditions
Brief summary
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.
Interventions
DRUGNaldemedine, an peripherally acting opioid antagonist
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).
Sponsors
Viatris Inc.
Professor Monique A. H. Steegers
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years) * A diagnosis of malignancy * Daily use of opioids * Use of laxatives * Experiencing constipation, defined as a Bowel Function Index (BFI) score ≥30 * Able to complete a Dutch-language questionnaire * Able to provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Bowel Function Index (BFI) score | From enrollement to one week after initiation of naldemedine treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A clinically meaningful improvement in constipation | From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation. | 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 | From enrollment to two weeks of treatment | — |
| The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores | From enrollment to two weeks of treatment with naldemedine | 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. |
| The change in Bowel Function Index (BFI) score | From enrollment to two weeks after initiation of naldemedine | — |
| Patient Satisfaction | From enrollment to two weeks of treatment with naldemedine | Patient satisfaction is measured on an 11-point Likert scale (0 = Not satisfied at all, 10 = Very satisfied). |
| Patient likelihood to recommend the use of naldemedine to other patients | From enrollment to two weeks of treatment with naldemedine | 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. |
| Continuation of naldemedine | From enrollment to two weeks after initiation of naldemedine | — |
Countries
Netherlands
Contacts
Primary ContactJosje Evers, MD
Outcome results
None listed