Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-Induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of opioid induced constipation (OIC)
- timeFrame
- 5 minutes
- description
- OIC diagnosed using Rome IV diagnostic criteria
Secondary outcomes (4)
- measure
- Impact of OIC on quality of life
- timeFrame
- 5 minutes
- description
- Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)
- measure
- Efficacy of treatment for OIC
- timeFrame
- 3 minutes
- description
- Bowel Function Index tool score Score 0-100 (better to worse)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDFallon 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
- BACKGROUNDGoodman 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
- BACKGROUNDvan 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
- BACKGROUNDCherny 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
- BACKGROUNDDavies 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
- BACKGROUNDWalter 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
- BACKGROUNDLee 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.