E-StOIC: European Study of Opioid Induced Constipation
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence of opioid induced constipation (OIC) [5 minutes]
OIC diagnosed using Rome IV diagnostic criteria
Secondary Outcome Measures
- Impact of OIC on quality of life [5 minutes]
Patient Assessment of Constipation Quality of Life tool score
- Efficacy of treatment for OIC [3 minutes]
Bowel Function Index tool score
- Adherence with treatment for OIC [5 min]
Study questionnaire
- Use of non-prescribed treatments for OIC [5 min]
Study questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or over
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Diagnosis of cancer
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Diagnosis of cancer pain or cancer treatment-related pain
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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:
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Unable to provide consent
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Unable to complete questionnaire
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Our Lady's Hospice & Care Services | Dublin | Ireland | D6W EV82 |
Sponsors and Collaborators
- University of Dublin, Trinity College
Investigators
- Principal Investigator: Andrew Davies, MD, University of Dublin, Trinity College
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- Fallon MT, Hanks GW. Morphine, constipation and performance status in advanced cancer patients. Palliat Med. 1999 Mar;13(2):159-60.
- 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.
- 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.
- 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.
- Walter S, Hallböök O, Gotthard R, Bergmark M, Sjödahl 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.
- PM2021/65