Clinical trial NCT04294550: Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Constipation Drug Induced
Cancer
Keywords: Opioid induced constipation
Cancer patients
Palliative care
Quality of life
PAC-QoL
Naloxegol
Lead sponsor: Fondazione ANT Italia ONLUS
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with constipation induced by opioids who do not respond to the usual laxatives, under naloxegol therapy (25mg/day) assisted at home by the palliative care program of Fondazione ANT Italia ONLUS.

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.


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.

Primary outcomes:
measure: Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
timeFrame: 4 weeks
Secondary outcomes:
measure: Objective constipation
timeFrame: 4 weeks
measure: Subjective constipation
timeFrame: 4 weeks
measure: Pain (Numeric Rating Scale)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Fondazione ANT Italia ONLUS
state: BO
Study officials:
affiliation: Fondazione ANT Italia ONLUS
name: Enrico Ruggeri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostan 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.