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OpenTrials
Completed

NCT Number: NCT05149833

European Study of Opioid Induced Constipation

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.

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norah Fagan

Dublin, D6W EV82, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of opioid induced constipation (OIC)

    Time frame: 5 minutes

    OIC diagnosed using Rome IV diagnostic criteria

Secondary outcomes

  1. Impact of OIC on quality of life

    Time frame: 5 minutes

    Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)

  2. Efficacy of treatment for OIC

    Time frame: 3 minutes

    Bowel Function Index tool score Score 0-100 (better to worse)

  3. Adherence with treatment for OIC No scale - yes / no options

    Time frame: 5 minutes

    Study questionnaire

  4. Use of non-prescribed treatments for OIC

    Time frame: 5 minutes

    Study questionnaire No scale - yes / no options

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Official study title

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

Acronym: E-StOIC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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