NCT04294550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

March 2, 2020

Last Update Submit

February 10, 2022

Conditions

Opioid UseConstipation Drug InducedCancer

Keywords

Opioid induced constipationCancer patientsPalliative careQuality of lifePAC-QoLNaloxegol

Outcome Measures

Primary Outcomes (1)

  • Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score

    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.

    4 weeks

Secondary Outcomes (3)

  • Objective constipation

    4 weeks

  • Subjective constipation

    4 weeks

  • Pain (Numeric Rating Scale)

    4 weeks

Interventions

NaloxegolOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • patient with pain not controlled by opioids;
  • therapy with other PAMORAs;
  • intestinal obstruction;
  • risk of intestinal perforation.
  • severe renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione ANT Italia ONLUS

Bologna, BO, 40128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34830889RESULT

MeSH Terms

Conditions

NeoplasmsOpioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

ConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Enrico Ruggeri, MD

    Fondazione ANT Italia ONLUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

September 1, 2018

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

IT(1)