Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience (NOCON)

Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Opioid Induced Constipation (OIC)
• Intervention / Treatment: Drug: Naldemedine, an peripherally acting opioid antagonist

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Josje Evers, MD; Phone Number: +31650087799; Email: j.evers@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Josje Evers, MD; Phone Number: +31650087799; Email: j.evers@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollement to one week after initiation of naldemedine treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Bowel Function Index (BFI) score		From enrollment to two weeks after initiation of naldemedine
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	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.	From enrollment to two weeks of treatment with naldemedine
Continuation of naldemedine		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").	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.	From enrollment to two weeks of treatment with naldemedine
A clinically meaningful improvement in constipation	The proportion of patients achieving a ≥12-point decline in the Bowel Function Index (BFI) score.	From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation.

Collaborators and Investigators

• Sponsor: Professor Monique A. H. Steegers
• Collaborators: Viatris Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Signs and Symptoms, Digestive; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Opioid-Induced Constipation; Neoplasms; naldemedine
• Other Study ID Numbers: 2025.0837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No