European Study of Opioid Induced Constipation

NCT05149833 | Completed

• 1 other identifier: PM2021/65
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Induced Constipation

Outcome Measures

Primary Outcomes (1)

• Prevalence of opioid induced constipation (OIC)

  OIC diagnosed using Rome IV diagnostic criteria

  5 minutes

Secondary Outcomes (4)

• Impact of OIC on quality of life

  5 minutes

• Efficacy of treatment for OIC

  3 minutes

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

  5 minutes

• Use of non-prescribed treatments for OIC

  5 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants may be inpatients, or outpatients at the study sites. Participants must meet all of the inclusion criteria for the study, and none of the exclusion criteria for the study. Participants must have a diagnosis of cancer and be on regular opioids for at least one week for cancer/ cancer treatment related pain.

You may qualify if:

• 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)

You may not qualify if:

• Unable to provide consent
• Unable to complete questionnaire

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Norah Fagan

Dublin, D6W EV82, Ireland

Location

Related Publications (8)

• Fallon MT, Hanks GW. Morphine, constipation and performance status in advanced cancer patients. Palliat Med. 1999 Mar;13(2):159-60. doi: 10.1191/026921699677653615. No abstract available.

  PMID: 10474699 BACKGROUND

• Goodman M, Low J, Wilkinson S. Constipation management in palliative care: a survey of practices in the United kingdom. J Pain Symptom Manage. 2005 Mar;29(3):238-44. doi: 10.1016/j.jpainsymman.2004.06.013.

  PMID: 15781174 BACKGROUND

• van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Quality of life and non-pain symptoms in patients with cancer. J Pain Symptom Manage. 2009 Aug;38(2):216-33. doi: 10.1016/j.jpainsymman.2008.08.014. Epub 2009 Jun 28.

  PMID: 19564094 BACKGROUND

• Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.

  PMID: 11331334 BACKGROUND

• Davies A, Leach C, Butler C, Gregory A, Henshaw S, Minton O, Shorthose K, Batsari KM. Opioid-induced constipation in patients with cancer: a "real-world," multicentre, observational study of diagnostic criteria and clinical features. Pain. 2021 Jan;162(1):309-318. doi: 10.1097/j.pain.0000000000002024.

  PMID: 32701649 BACKGROUND

• Walter S, Hallbook O, Gotthard R, Bergmark M, Sjodahl R. A population-based study on bowel habits in a Swedish community: prevalence of faecal incontinence and constipation. Scand J Gastroenterol. 2002 Aug;37(8):911-6. doi: 10.1080/003655202760230865.

  PMID: 12229965 BACKGROUND

• Lee TH, Choi SC, Park MI, Park KS, Shin JE, Kim SE, Jung KW, Koo HS, Kim WJ, Cho YK, Kim YS, Lee JS. Constipation misperception is associated with gender, marital status, treatment utilization and constipation symptoms experienced. J Neurogastroenterol Motil. 2014 Jul 31;20(3):379-87. doi: 10.5056/jnm14011.

  PMID: 24935009 BACKGROUND

• Davies A, Fagan N, Power J, Taylor A. 'Constipation': One word, many meanings amongst persons with cancer: An observational study. Palliat Med. 2025 May;39(5):553-562. doi: 10.1177/02692163251325711. Epub 2025 Mar 12.

  PMID: 40071858 DERIVED

MeSH Terms

Conditions

Opioid-Induced Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Davies, MD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Palliative Medicine

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: December 8, 2021
• Study Start: September 16, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)