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

Fondazione ANT Italia ONLUS

Status: Completed

Conditions: Constipation Drug Induced; Opioid Use; Cancer

Treatments: Other: Naloxegol

Study type: Observational

Funder types: Other

Identifiers

NCT04294550

293/2018/OSS/AUSLBO

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.