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NCT04350112 Clinical Trial

Study of Opioid-Induced Constipation 1 Project

Cancer Clinical Trial

— StOIC-1  

Official title:
An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04350112
Other study ID # StOIC-1 Project
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 21, 2017
Est. completion date August 30, 2019

Study information
Verified date April 2020
Source Royal Surrey County Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

Description:

StOIC-1 is an observational study, and will involve a single visit (see below for schedule).

The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status

The participants will be asked the following questions:

1. Simple question - "Are you constipated?" [Options - yes / no / unsure]

2. European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' [Options - yes / no / unsure]

3. Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' [Options - yes / no / unsure

4. Rome IV diagnostic criteria for OIC

The participants will also be asked to complete:

1. Bowel function index (BFI). The BFI is a validated, 3 item, patient-reported tool for assessing the treatment of OIC. A BFI score of ≥30 indicates suboptimally treated OIC.

2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL). The PAC-QOL is a validated, 28-item, patient-reported tool for assessing the impact of constipation over time.

3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF). The MSAS-SF is a validated, 32 item, patient-reported tool for assessing physical and psychological symptoms in cancer patients.

The participant will also undergo a palliative care specialist assessment for constipation / OIC. The palliative care specialist will be asked to review the patient with regard to their bowel function, and then asked the following questions: a) does the patient have constipation? [Options - yes / no / unsure]; b) (if appropriate) does the patient have opioid-induced constipation? [Options - yes / no / unsure]; c) (if appropriate) does the patient have additional causes of constipation? [Options - yes / no / unsure]; d) (if appropriate) what additional causes of constipation?I

Recruitment information / eligibility
Status Completed
Enrollment 1007
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week

Exclusion Criteria:

- Inability to give informed consent; inability to complete questionnaire

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinical assessment
Clinical assessment (history, examination) is gold standard for diagnosing constipation - gold standard will be compared with simple question about constipation, Rome IV diagnostic criteria for OIC, and common definitions of constipation for constipation / OIC

Locations
Country Name City State
United Kingdom Hospice of St. Francis Berkhamstead Hertfordshire
United Kingdom Birmingham St. Mary's Hospice Birmingham West Midlands
United Kingdom Brighton & Sussex University Hospitals Brighton East Sussex
United Kingdom St. Raphael's Hospice Cheam London
United Kingdom Leckhampton Court Hospice Cheltenham Gloucestershire
United Kingdom St. Catherine's Hospice Crawley West Sussex
United Kingdom Royal Surrey County Hospital Guildford Surrey
United Kingdom St. Gemma's Hospice Leeds Yorkshire
United Kingdom Wheatfields Hospice Leeds Yorkshire
United Kingdom St. Giles Hospice Lichfield Staffordshire
United Kingdom Heart of Kent Hospice Maidstone Kent
United Kingdom Nottingham University Hospitals Nottingham Nottinghamshire
United Kingdom Wisdom Hospice Rochester Kent
United Kingdom St. Luke's Hospice Sheffield Yorkshire
United Kingdom Royal Cornwall Hospital Truro Cornwall
United Kingdom St Margaret's Hospice Yeovil Somerset

Sponsors (2)
Lead Sponsor Collaborator
Royal Surrey County Hospital NHS Foundation Trust Kyowa Hakko Kirin UK, Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pm — View Citation

Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: — View Citation

Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. — View Citation

Larkin PJ, Sykes NP, Centeno C, Ellershaw JE, Elsner F, Eugene B, Gootjes JR, Nabal M, Noguera A, Ripamonti C, Zucco F, Zuurmond WW; European Consensus Group on Constipation in Palliative Care. The management of constipation in palliative care: clinical p — View Citation

Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. — View Citation

Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18. pii: S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. [Epub ahead of print] — View Citation

Rentz AM, Yu R, Müller-Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ. 2009;12(4):371-83. doi: 10.3111/13696990903430481. — View Citation

Ueberall MA, Müller-Lissner S, Buschmann-Kramm C, Bosse B. The Bowel Function Index for evaluating constipation in pain patients: definition of a reference range for a non-constipated population of pain patients. J Int Med Res. 2011;39(1):41-50. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of opioid-induced constipation Clinician assessment 1 week
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