NCT04294550

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

A Multicenter, Observational Prospective Study on Quality of Life (QOL) in Advanced Cancer Patients With Opioid-induced Constipation (OIC) Treated at Home With Naloxegol According to the Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Fondazione ANT Italia ONLUS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opioid Use
• Constipation Drug Induced
• Cancer

Interventions

Type	Name	Description
OTHER	Naloxegol	28 days of therapy with 25 mg/day of Naloxegol on cancer patients using opioids and suffering for opioids induced constipation not relieved by first-line laxatives.

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2020-03-04
• Last updated: 2022-02-28

Locations

1 site across 1 country: Italy