Naldemedine for opioid-induced constipation in people with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Josje Evers, MD
• Email: j.evers@amsterdamumc.nl
• Phone: +31650087799

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.