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Opioid-induced ConstipationStOIC-2NCT04404933

Study of Opioid-Induced Constipation 2 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 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. 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?
Treatment algorithm for OIC
How many people
100 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: Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research

Who may be able to join

  • 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

Who cannot join

  • As per StOIC 1: inability to give informed consent; inability yo complete questionnaire
  • Prognosis > 1 month

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 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.

Read the detailed description

StOIC-2 is an observational study of routine clinical practice, and will involve four assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2 study will be identified from StOIC 1 study (CancerTrials.gov registry reference number - NCT04350112). Visit 1 for StOIC 2 study will correspond to the assessment for StOIC 1 study.

Patients will be managed according to a treatment algorithm (see below), which is based on a review of the evidence (and which is the basis of the Multinational Association for Supportive Care in Cancer (MASCC) guideline on the treatment of constipation in patients with advanced cancer). The decision to change treatment is based on efficacy / lack of efficacy (as determined by the Bowel Function Index (see below), or the development of adverse effects.

Step 1: Conventional Laxatives

  • Choice of laxatives at the discretion of the clinical team
  • Combination of softener and stimulant laxative
  • Laxatives to be prescribed on a regular basis

Step 2: Peripherally acting mu opioid receptor antagonist (PAMORA)

  • Choice of PAMORA at the discretion of clinical team
  • Either oral naloxegol or subcutaneous methylnaltrexone
  • PAMORA to be prescribed on a regular basis

Step 3: PAMORA + Conventional Laxatives

  • Choice of combination at the discretion of the PI/clinical team
  • Combination to be prescribed on a regular basis

Step 4: Other options

  • Choice of other option at discretion of clinical team:
  • Bowel cleansing preparations (e.g. Picolax)
  • Suppositories
  • Enemas
  • Manual evacuation
  • Other drugs (e.g. lubiprostone, prucalopride)

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 (every visit); e) Eastern Cooperative Oncology Group performance status.

The participants will also be asked to complete;

  1. Bowel Function Index (BFI) - every visit. 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) - first and last visit. 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) - first and last visit. The MSAS-SF is a validated, 32 item, patient reported tool for assessing physical and psychological symptoms in cancer patients.

Data will also be collected on adverse effects from medication / interventions, and reasons for withdrawal from the study.

Being tested
Treatment algorithm for OIC
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.

  • Treatment algorithm for OICOther

    Treatment Algorithm for OIC

What is being measured

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

  1. Resolution of OIC

    BFI < 30

    Measured: 28 days

Secondary outcomes (1)

  1. Improvement in BFI

    BFI improved by 12

    Measured: 28 days

Timeline

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

  1. First posted28 May 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
Other
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404933
Sponsor's protocol ID
StOIC-2 Project
Acronym
StOIC-2
Status last verified
Apr 2020
First submitted
22 May 2020
Last updated
28 May 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

  • 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.

    PubMed 31396746

  • 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

  • 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

  • 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

  • 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

  • Davies 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.

    PubMed 34348942

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 3 inclusion and 2 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 28 May 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?

Resolution of OIC (time frame: 28 days). 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 NCT04404933, which also lists 6 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 28 May 2020.

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