Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

Study Overview
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Brief Summary
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Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.

Official Title
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Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study

Conditions
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Opioid-induced Constipation

Intervention / Treatment
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* Drug: Naloxegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Cancer Treatment with opioids OIC symptoms Inadequate response to laxatives Karnofsky equal or above 50 Ambulatory Must be able to complete questionnaire forms Exclusion Criteria: at the start of the study: Hypersensitivity to Naloxegol or vehicle Suspicion or high risk of gastrointestinal block High risk of GI perforation Severe liver failure Pregnancy or breastfeeding Use of potent CYP3A4 inhibitors Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives. | Drug: Naloxegol<br>* 25 mg oral naloxegol once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Quality of Life | Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Constipation Symptoms | Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire | 15 days | 
| Assessment of Constipation Symptoms | Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire | 1 month | 
| Assessment of Constipation Symptoms | Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire | 3 months | 
| Assessment of Constipation Symptoms | Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naloxegol, PAMORA