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NCT Number: NCT04294550

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

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.

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Key information

Conditions

Opioid Use Cancer Chemically-Induced Disorders Constipation Constipation Drug Induced Mental Disorders Narcotic-Related Disorders Neoplasms Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione ANT Italia ONLUS

Bologna, BO, 40128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naloxegol

Other

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.

Primary outcomes

  1. 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

  1. Objective constipation

    Time frame: 4 weeks

    Change of objective constipation evaluated by number of weekly evacuations.

  2. Subjective constipation

    Time frame: 4 weeks

    Change of subjective constipation evaluated by Bowel Function Index (BFI). The BFI is a physician-administered, patient-assessment scale made up of three items: (1) ease of defecation, (2) feeling of incomplete bowel evacuation, and (3) personal judgement of constipation during the last 7 days. The physician asks the patient to rate his or her impression of each of the three items during the previous week on a scale from 0 to 100, with 0 signifying 'not at all' and 100 signifying 'very strong'. The score is then calculated as the average of the three components of the scale with each component being weighted equally. The BFI total score remains on a scale of 0 to 100 with higher scores indicating greater constipation.

  3. Pain (Numeric Rating Scale)

    Time frame: 4 weeks

    Change of pain assessed by Numeric Rating Scale (NRS). The NRS is a 11-points numeric scale through participants were asked to rate their average pain intensity by selecting a single number from 0 to 10. Higher scores indicate a more severe pain.

Sponsors and collaborators

Lead sponsor

Fondazione ANT Franco Pannuti ETS

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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