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

10. februar 2022 opdateret af: Fondazione ANT Italia ONLUS

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • BO
      • Bologna, BO, Italien, 40128
        • Fondazione ANT Italia ONLUS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
Tidsramme: 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.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective constipation
Tidsramme: 4 weeks
Change of objective constipation evaluated by number of weekly evacuations.
4 weeks
Subjective constipation
Tidsramme: 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.
4 weeks
Pain (Numeric Rating Scale)
Tidsramme: 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.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione ANT Italia ONLUS

Efterforskere

  • Ledende efterforsker: Enrico Ruggeri, MD, Fondazione ANT Italia ONLUS

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2018

Primær færdiggørelse (Faktiske)

31. december 2020

Studieafslutning (Faktiske)

31. marts 2021

Datoer for studieregistrering

Først indsendt

2. marts 2020

Først indsendt, der opfyldte QC-kriterier

2. marts 2020

Først opslået (Faktiske)

4. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 293/2018/OSS/AUSLBO

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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