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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Naldemedine, 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).

Первичные конечные точки

• The change in Bowel Function Index (BFI) score [Срок оценки: From enrollement to one week after initiation of naldemedine treatment]

Вторичные конечные точки (7)

• The change in Bowel Function Index (BFI) score [Срок оценки: From enrollment to two weeks after initiation of naldemedine]
• A clinically meaningful improvement in constipation [Срок оценки: From baseline to one week after treatment initiation and from baseline to two weeks after treatment initiation.]
• The prevalence of persistent constipation, defined as a BFI score ≥ 30 [Срок оценки: From enrollment to two weeks of treatment]
• The change in Patient Assessment of Constipation, Quality of Life (PAC-QoL) scores [Срок оценки: From enrollment to two weeks of treatment with naldemedine]
• Continuation of naldemedine [Срок оценки: From enrollment to two weeks after initiation of naldemedine]
• Patient Satisfaction [Срок оценки: From enrollment to two weeks of treatment with naldemedine]
• Patient likelihood to recommend the use of naldemedine to other patients [Срок оценки: From enrollment to two weeks of treatment with naldemedine]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT07231796 · 2025.0837

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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