Study of Opioid-Induced Constipation 2 Project
StOIC-2
An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
1 other identifier
observational
100
1 country
16
Brief Summary
The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer. The objectives of the project are to determine: a) efficacy of a treatment algorithm to manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs / other interventions to manage OIC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedMay 28, 2020
April 1, 2020
2 years
May 22, 2020
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of OIC
BFI \< 30
28 days
Secondary Outcomes (1)
Improvement in BFI
28 days
Interventions
Treatment Algorithm for OIC
Eligibility Criteria
Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research
You may qualify if:
- As per StOIC 1: age \> 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week
- Diagnosis of OIC as defined by the Rome IV criteria (Lacy et al, 2016)
- Diagnosis of inadequately treated OIC as defined by BFI \> 30
You may not qualify if:
- As per StOIC 1: inability to give informed consent; inability yo complete questionnaire
- Prognosis \> 1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ, United Kingdom
Brighton & Sussex University Hospitals
Brighton, East Sussex, BN2 5BE, United Kingdom
Leckhampton Court Hospice
Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom
Hospice of St. Francis
Berkhamstead, Hertfordshire, HP43GW, United Kingdom
Heart of Kent Hospice
Maidstone, Kent, ME20 7PU, United Kingdom
Wisdom Hospice
Rochester, Kent, ME1 2NU, United Kingdom
St. Raphael's Hospice
Cheam, London, SM3 9DX, United Kingdom
Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom
St Margaret's Hospice
Yeovil, Somerset, BA20 2HU, United Kingdom
St. Giles Hospice
Lichfield, Staffordshire, WS14 9LH, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Birmingham St. Mary's Hospice
Birmingham, West Midlands, B29 7DA, United Kingdom
St. Catherine's Hospice
Crawley, West Sussex, RH10 6BH, United Kingdom
St. Gemma's Hospice
Leeds, Yorkshire, LS17 6QD, United Kingdom
Wheatfields Hospice
Leeds, Yorkshire, LS6 2AE, United Kingdom
St. Luke's Hospice
Sheffield, Yorkshire, S11 9NE, United Kingdom
Related Publications (6)
Davies A, Leach C, Caponero R, Dickman A, Fuchs D, Paice J, Emmanuel A. MASCC recommendations on the management of constipation in patients with advanced cancer. Support Care Cancer. 2020 Jan;28(1):23-33. doi: 10.1007/s00520-019-05016-4. Epub 2019 Aug 9.
PMID: 31396746RESULTRentz AM, Yu R, Muller-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.
PMID: 19912069RESULTArgoff 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/pme.12937. Epub 2015 Nov 19.
PMID: 26582720RESULTMarquis 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. doi: 10.1080/00365520510012208.
PMID: 16036506RESULTChang 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. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
PMID: 10964347RESULTDavies AN, Leach C, Butler C, Patel SD, Shorthose K, Batsari K. Opioid-induced constipation: a stepwise treatment algorithm feasibility study. BMJ Support Palliat Care. 2023 Dec 7;13(e2):e446-e453. doi: 10.1136/bmjspcare-2020-002754.
PMID: 34348942DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Davies, MD
Consultant Palliative Medicine
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 28, 2020
Study Start
August 21, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
May 28, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
Currently, there are no plans to make IPD available to other researchers