Study of Opioid-Induced Constipation 2 Project (StOIC-2)

May 22, 2020 updated by: Royal Surrey County Hospital NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
        • Leckhampton Court Hospice
    • Hertfordshire
      • Berkhamstead, Hertfordshire, United Kingdom, HP43GW
        • Hospice of St. Francis
    • Kent
      • Maidstone, Kent, United Kingdom, ME20 7PU
        • Heart of Kent Hospice
      • Rochester, Kent, United Kingdom, ME1 2NU
        • Wisdom Hospice
    • London
      • Cheam, London, United Kingdom, SM3 9DX
        • St. Raphael's Hospice
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
        • Nottingham University Hospitals
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA20 2HU
        • St Margaret's Hospice
    • Staffordshire
      • Lichfield, Staffordshire, United Kingdom, WS14 9LH
        • St. Giles Hospice
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B29 7DA
        • Birmingham St. Mary's Hospice
    • West Sussex
      • Crawley, West Sussex, United Kingdom, RH10 6BH
        • St. Catherine's Hospice
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS17 6QD
        • St. Gemma's Hospice
      • Leeds, Yorkshire, United Kingdom, LS6 2AE
        • Wheatfields Hospice
      • Sheffield, Yorkshire, United Kingdom, S11 9NE
        • St. Luke's Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of OIC
Time Frame: 28 days
BFI < 30
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in BFI
Time Frame: 28 days
BFI improved by 12
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Collaborators

Kyowa Hakko Kirin UK, Ltd.

Investigators

  • Principal Investigator: Andrew Davies, MD, Consultant Palliative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StOIC-2 Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Currently, there are no plans to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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