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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Use
- Sponsor
- Fondazione ANT Italia ONLUS
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •cancer patients with advanced disease;
- •age higher than 18 years;
- •mentally competent;
- •naloxegol therapy for no more than 1 week according to clinical practice;
- •sign of a written informed consent.
Exclusion Criteria
- •patient with pain not controlled by opioids;
- •therapy with other PAMORAs;
- •intestinal obstruction;
- •risk of intestinal perforation.
- •severe renal failure.
Outcomes
Primary Outcomes
Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
Time Frame: 4 weeks
Change of quality of life evaluated by Patient Assessment of Constipation Quality-of-Life (PAC-QoL) at T0 and T28. Each item of the 28-item questionnaire was scored on a 5-point Likert-type scale from 0 to 4, with (0 = none/not at all, 1 = a little bit/a little bit of the time, 2 = moderately/some of the time, 3 = quite a bit/most of the time, 4 = extremely/all the time). Scores were reported overall and for each of the four subscales (physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction). An improvement (reduction) of ≥1 point in PAC-QOL score was considered clinically significant based on previous validation studies.
Secondary Outcomes
- Subjective constipation(4 weeks)
- Pain (Numeric Rating Scale)(4 weeks)
- Objective constipation(4 weeks)