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- Essai clinique NCT04294550
Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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BO
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Bologna, BO, Italie, 40128
- Fondazione ANT Italia ONLUS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
Délai: 4 weeks
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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.
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4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective constipation
Délai: 4 weeks
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Change of objective constipation evaluated by number of weekly evacuations.
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4 weeks
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Subjective constipation
Délai: 4 weeks
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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.
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4 weeks
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Pain (Numeric Rating Scale)
Délai: 4 weeks
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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.
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4 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Enrico Ruggeri, MD, Fondazione ANT Italia ONLUS
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Troubles liés à une substance
- Signes et symptômes digestifs
- Troubles liés aux stupéfiants
- Constipation
- Constipation induite par les opioïdes
- Effets physiologiques des médicaments
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Antagonistes des stupéfiants
- Naloxégol
Autres numéros d'identification d'étude
- 293/2018/OSS/AUSLBO
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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