Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2017-08-21
2019-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Treatment algorithm for OIC
Treatment Algorithm for OIC
Eligibility Criteria
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Inclusion Criteria
* 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
* Prognosis \> 1 month
18 Years
ALL
No
Sponsors
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Kyowa Hakko Kirin UK, Ltd.
INDUSTRY
Royal Surrey County Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Andrew Davies, MD
Role: PRINCIPAL_INVESTIGATOR
Consultant Palliative Medicine
Locations
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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
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Birmingham St. Mary's Hospice
Birmingham, West Midlands, United Kingdom
St. Catherine's Hospice
Crawley, West Sussex, United Kingdom
St. Gemma's Hospice
Leeds, Yorkshire, United Kingdom
Wheatfields Hospice
Leeds, Yorkshire, United Kingdom
St. Luke's Hospice
Sheffield, Yorkshire, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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StOIC-2 Project
Identifier Type: -
Identifier Source: org_study_id
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