Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Constipation Drug Induced | — | UNRESOLVED | — |
| Opioid Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Naloxegol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
- timeFrame
- 4 weeks
- description
- 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 (3)
- measure
- Objective constipation
- timeFrame
- 4 weeks
- description
- Change of objective constipation evaluated by number of weekly evacuations.
- measure
- Subjective constipation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTOstan R, Gambino G, Malavasi I, Ronga G, Solipaca M, Spunghi M, Varani S, Pannuti R, Ruggeri E. Can Naloxegol Therapy Improve Quality of Life in Patients with Advanced Cancer? Cancers (Basel). 2021 Nov 16;13(22):5736. doi: 10.3390/cancers13225736. PMID 34830889