Naldemedine for opioid-induced constipation in people with cancer
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07231796
This study will try naldemedine, a gut-acting opioid blocker, to relieve opioid-induced constipation in adults with cancer who still have constipation despite laxatives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07231796 on ClinicalTrials.gov |
What this trial studies
This observational study will collect real-world medical outcomes and patient-reported experiences from adults with cancer who take daily opioids and have opioid-induced constipation despite laxatives. Participants treated with naldemedine at Amsterdam UMC will be followed using medical records and Dutch-language questionnaires to measure bowel function (including the Bowel Function Index) and tolerability. The study excludes patients who used other opioid antagonists within the last month or who have suspected gastrointestinal perforation, and it does not randomize or assign treatments. The aim is to describe how naldemedine performs in everyday clinical practice and how patients feel while using it.
Who should consider this trial
Good fit: Adults (≥18) with a cancer diagnosis who take daily opioids, still have constipation despite laxatives (BFI ≥30), can read Dutch, and can give written informed consent are the ideal candidates.
Not a fit: Patients with suspected gastrointestinal perforation, those who used another opioid antagonist in the past month, or whose constipation is not caused by opioids may not benefit from this treatment.
Why it matters
Potential benefit: If successful, naldemedine could relieve opioid-induced constipation without reducing pain control, improving bowel comfort and quality of life.
How similar studies have performed: Randomized trials and regulatory approvals have shown naldemedine can relieve opioid-induced constipation, though real-world data specifically in cancer populations are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Josje Evers, MD
- Email: j.evers@amsterdamumc.nl
- Phone: +31650087799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Opioid Induced Constipation