European Study of Opioid Induced Constipation

Opioid-Induced Constipation Clinical Trial

— E-StOIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149833
• Other study ID #: PM2021/65
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: University of Dublin, Trinity College
• Contact: Norah Fagan
• Phone: 01-4066235
• Email: nfagan[@]olh.ie
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1320
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Locations

Country	Name	City	State
Ireland	Norah Fagan	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of opioid induced constipation (OIC)	OIC diagnosed using Rome IV diagnostic criteria	5 minutes
Secondary	Impact of OIC on quality of life	Patient Assessment of Constipation Quality of Life tool score Scale 0-4 (better to worse)	5 minutes
Secondary	Efficacy of treatment for OIC	Bowel Function Index tool score Score 0-100 (better to worse)	3 minutes
Secondary	Adherence with treatment for OIC No scale - yes / no options	Study questionnaire	5 minutes
Secondary	Use of non-prescribed treatments for OIC	Study questionnaire No scale - yes / no options	5 minutes