Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol

Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain.
This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program.
The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score<30), pain assessment by NRS.

阿片类药物诱导性便秘（Opioid-Induced Constipation, OIC）常与姑息治疗（palliative care, PC）场景下患者的生活质量受损密切相关。在外周作用μ阿片受体拮抗剂（Peripherally-Acting Mu-Opioid Receptor Antagonists）类药物中，纳洛昔格尔（Naloxegol）是治疗非癌性疼痛患者OIC、并改善OIC相关生活质量维度的最有效药物。
本观察性研究旨在评估为期4周的纳洛昔格尔治疗，对接受居家姑息照护项目支持的晚期癌症合并OIC患者的生活质量的影响。
本研究纳入符合罗马IV诊断标准（Rome IV criteria）、经一线泻剂治疗无效的癌症合并OIC患者，予25mg/日的纳洛昔格尔起始治疗。于治疗初始（T0）及治疗28天后（T28）评估的主要参数包括：便秘患者生活质量自评量表（Patient Assessment of Constipation Quality-of-Life, PAC-QoL，含4个维度：躯体不适、心理社会不适、担忧与顾虑、满意度）、客观排便指标（每周排便次数）与主观便秘评估（肠功能指数Bowel Function Index, BFI，正常评分＜30分），以及数字疼痛评分量表（Numeric Rating Scale, NRS）疼痛评估。