Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced Constipation: Clinical Outcomes and Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change in Bowel Function Index (BFI) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The change in Bowel Function Index (BFI) score
时间窗: 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.
次要结局
- The change in Bowel Function Index (BFI) score(From enrollment to two weeks after initiation of naldemedine)
- A clinically meaningful improvement in constipation(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(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)
- Continuation of naldemedine(From enrollment to two weeks after initiation of naldemedine)
- Patient Satisfaction(From enrollment to two weeks of treatment with naldemedine)
- Patient likelihood to recommend the use of naldemedine to other patients(From enrollment to two weeks of treatment with naldemedine)
研究者
Professor Monique A. H. Steegers
Prof dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)