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European Study of Opioid Induced Constipation

An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid Induced Constipation (OIC) in European Patients With Cancer Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05149833
Acronym
E-StOIC
Enrollment
1200
Registered
2021-12-08
Start date
2021-09-16
Completion date
2024-07-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Induced Constipation

Brief summary

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure. OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

Detailed description

This European study follows on from a United Kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage OIC. Moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in OIC management in the different European countries. Previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. The aim of the project is to investigate OIC in a real world / heterogenous group of European patients with cancer.

Interventions

None listed

Sponsors

University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or over * Diagnosis of cancer * Diagnosis of cancer pain or cancer treatment-related pain * Taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / weak opioid; or opioid for moderate to severe pain / strong opioid)

Exclusion criteria

* Unable to provide consent * Unable to complete questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of opioid induced constipation (OIC)5 minutesOIC diagnosed using Rome IV diagnostic criteria

Secondary

MeasureTime frameDescription
Impact of OIC on quality of life5 minutesPatient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)
Efficacy of treatment for OIC3 minutesBowel Function Index tool score Score 0-100 (better to worse)
Adherence with treatment for OIC No scale - yes / no options5 minutesStudy questionnaire
Use of non-prescribed treatments for OIC5 minutesStudy questionnaire No scale - yes / no options

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026