Study of Opioid-Induced Constipation 2 Project

Cancer Clinical Trial

— StOIC-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404933
• Other study ID #: StOIC-2 Project
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: April 2020
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Constipation
• Opioid-induced Constipation

Intervention

Other:
• Treatment algorithm for OIC
Treatment Algorithm for OIC

Locations

Country	Name	City	State
United Kingdom	Hospice of St. Francis	Berkhamstead	Hertfordshire
United Kingdom	Birmingham St. Mary's Hospice	Birmingham	West Midlands
United Kingdom	Brighton & Sussex University Hospitals	Brighton	East Sussex
United Kingdom	St. Raphael's Hospice	Cheam	London
United Kingdom	Leckhampton Court Hospice	Cheltenham	Gloucestershire
United Kingdom	St. Catherine's Hospice	Crawley	West Sussex
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	St. Gemma's Hospice	Leeds	Yorkshire
United Kingdom	Wheatfields Hospice	Leeds	Yorkshire
United Kingdom	St. Giles Hospice	Lichfield	Staffordshire
United Kingdom	Heart of Kent Hospice	Maidstone	Kent
United Kingdom	Nottingham University Hospitals	Nottingham	Nottinghamshire
United Kingdom	Wisdom Hospice	Rochester	Kent
United Kingdom	St. Luke's Hospice	Sheffield	Yorkshire
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall
United Kingdom	St Margaret's Hospice	Yeovil	Somerset

Sponsors (2)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust	Kyowa Hakko Kirin UK, Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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/pm — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rentz AM, Yu R, Müller-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of OIC	BFI < 30	28 days
Secondary	Improvement in BFI	BFI improved by 12	28 days