NCT04350112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,007

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 13, 2020

Last Update Submit

April 15, 2020

Conditions

Opioid-induced ConstipationCancerCancer Pain

Keywords

Opioid-induced constipation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of opioid-induced constipation

    Clinician assessment

    1 week

Interventions

Clinical assessmentOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 subjects that are either inpatients or outpatients at study sites (hospitals and hospices in the United Kingdom)

You may qualify if:

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

You may not qualify if:

  • Inability to give informed consent; inability to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

Brighton & Sussex University Hospitals

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Leckhampton Court Hospice

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

Location

Hospice of St. Francis

Berkhamstead, Hertfordshire, HP43GW, United Kingdom

Location

Heart of Kent Hospice

Maidstone, Kent, ME20 7PU, United Kingdom

Location

Wisdom Hospice

Rochester, Kent, ME1 2NU, United Kingdom

Location

St. Raphael's Hospice

Cheam, London, SM3 9DX, United Kingdom

Location

Nottingham University Hospitals

Nottingham, Nottinghamshire, United Kingdom

Location

St Margaret's Hospice

Yeovil, Somerset, BA20 2HU, United Kingdom

Location

St. Giles Hospice

Lichfield, Staffordshire, WS14 9LH, United Kingdom

Location

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Birmingham St. Mary's Hospice

Birmingham, West Midlands, B29 7DA, United Kingdom

Location

St. Catherine's Hospice

Crawley, West Sussex, RH10 6BH, United Kingdom

Location

St. Gemma's Hospice

Leeds, Yorkshire, LS17 6QD, United Kingdom

Location

Wheatfields Hospice

Leeds, Yorkshire, LS6 2AE, United Kingdom

Location

St. Luke's Hospice

Sheffield, Yorkshire, S11 9NE, United Kingdom

Location

Related Publications (8)

  • 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: 10.1111/nmo.12417. Epub 2014 Aug 28.

    PMID: 25164154RESULT

  • 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 practice recommendations. Palliat Med. 2008 Oct;22(7):796-807. doi: 10.1177/0269216308096908.

    PMID: 18838491RESULT

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

    PMID: 27144627RESULT

  • 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/pme.12937. Epub 2015 Nov 19.

    PMID: 26582720RESULT

  • 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. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.

    PMID: 10964347RESULT

  • 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. doi: 10.1080/00365520510012208.

    PMID: 16036506RESULT

  • Rentz 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: 19912069RESULT

  • Ueberall MA, Muller-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. doi: 10.1177/147323001103900106.

    PMID: 21672306RESULT

MeSH Terms

Conditions

Opioid-Induced ConstipationNeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

ConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic Manifestations

Study Officials

  • Andrew N Davies, MD

    Consultant Palliative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

August 21, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

April 16, 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

Locations

GB(16)