Study of Opioid-Induced Constipation 2 Project

Completed

• Conditions: Opioid-induced Constipation; Cancer; Cancer Pain

• Registration Number: NCT04404933
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

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.

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 Timeline

• Study Start: 2017-08-21
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-04
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution of OIC	28 days	BFI \< 30

Secondary Outcome Measures

Name	Time	Method
Improvement in BFI	28 days	BFI improved by 12

Trial Locations

Locations (16)

Royal Cornwall Hospital; 🇬🇧 Truro, Cornwall, United Kingdom

Brighton & Sussex University Hospitals; 🇬🇧 Brighton, East Sussex, United Kingdom

Leckhampton Court Hospice; 🇬🇧 Cheltenham, Gloucestershire, United Kingdom

Hospice of St. Francis; 🇬🇧 Berkhamstead, Hertfordshire, United Kingdom

Heart of Kent Hospice; 🇬🇧 Maidstone, Kent, United Kingdom

Wisdom Hospice; 🇬🇧 Rochester, Kent, United Kingdom

St. Raphael's Hospice; 🇬🇧 Cheam, London, United Kingdom

Nottingham University Hospitals; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom

St Margaret's Hospice; 🇬🇧 Yeovil, Somerset, United Kingdom

St. Giles Hospice; 🇬🇧 Lichfield, Staffordshire, United Kingdom

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