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Opioid-induced ConstipationStOIC-1NCT04350112

Study of Opioid-Induced Constipation 1 Project

An observational study of Opioid-induced Constipation and Cancer, run by Royal Surrey County Hospital NHS Foundation Trust at 16 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-induced Constipation, Cancer, Cancer Pain
What is being tested?
Clinical assessment
Type of treatment
Injection or infusion
How many people
1,007 participants
Where
16 sitesUnited Kingdom
Study dates
21 Aug 2017to 30 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Inability to give informed consent; inability to complete questionnaire

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United Kingdom16 sites

  • Hospice of St. Francis

    Berkhamstead, Hertfordshire, HP43GW

  • Birmingham St. Mary's Hospice

    Birmingham, West Midlands, B29 7DA

  • Brighton & Sussex University Hospitals

    Brighton, East Sussex, BN2 5BE

  • St. Raphael's Hospice

    Cheam, London, SM3 9DX

  • Leckhampton Court Hospice

    Cheltenham, Gloucestershire, GL53 0QJ

  • St. Catherine's Hospice

    Crawley, West Sussex, RH10 6BH

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • St. Gemma's Hospice

    Leeds, Yorkshire, LS17 6QD

  • Wheatfields Hospice

    Leeds, Yorkshire, LS6 2AE

  • St. Giles Hospice

    Lichfield, Staffordshire, WS14 9LH

  • Heart of Kent Hospice

    Maidstone, Kent, ME20 7PU

  • Nottingham University Hospitals

    Nottingham, Nottinghamshire

  • Wisdom Hospice

    Rochester, Kent, ME1 2NU

  • St. Luke's Hospice

    Sheffield, Yorkshire, S11 9NE

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LQ

  • St Margaret's Hospice

    Yeovil, Somerset, BA20 2HU

Other trials in United Kingdom

About this study

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

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.

Read the detailed 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

Being tested
Clinical assessment
Keywords
Opioid-induced constipation
Medical subject headings
Opioid-Induced Constipation, Neoplasms, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of opioid-induced constipation

    Clinician assessment

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start21 Aug 2017
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,007 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04350112
Sponsor's protocol ID
StOIC-1 Project
Acronym
StOIC-1
Status last verified
Apr 2020
First submitted
13 Apr 2020
Last updated
16 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently, there are no plans to make IPD available to other researchers

Publications

  • 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.

    PubMed 25164154

  • 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.

    PubMed 18838491

  • 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.

    PubMed 27144627

  • 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.

    PubMed 26582720

  • 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.

    PubMed 10964347

  • 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.

    PubMed 16036506

  • 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.

    PubMed 19912069

  • 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.

    PubMed 21672306

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-induced Constipation and Cancer, run by Royal Surrey County Hospital NHS Foundation Trust at 16 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of opioid-induced constipation (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350112, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.

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