Clinical trial NCT04404933: Study of Opioid-Induced Constipation 2 Project
Official title: An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-induced Constipation
Cancer
Cancer Pain
Keywords: Opioid-induced constipation
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Kyowa Hakko Kirin UK, Ltd.
First posted: 2020-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of OIC
timeFrame: 28 days
Secondary outcomes:
measure: Improvement in BFI
timeFrame: 28 days
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospitals
state: East Sussex
city: Cheltenham
country: United Kingdom
facility: Leckhampton Court Hospice
state: Gloucestershire
city: Berkhamstead
country: United Kingdom
facility: Hospice of St. Francis
state: Hertfordshire
city: Maidstone
country: United Kingdom
facility: Heart of Kent Hospice
state: Kent
city: Rochester
country: United Kingdom
facility: Wisdom Hospice
state: Kent
city: Cheam
country: United Kingdom
facility: St. Raphael's Hospice
state: London
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
state: Nottinghamshire
city: Yeovil
country: United Kingdom
facility: St Margaret's Hospice
state: Somerset
city: Lichfield
country: United Kingdom
facility: St. Giles Hospice
state: Staffordshire
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Birmingham
country: United Kingdom
facility: Birmingham St. Mary's Hospice
state: West Midlands
city: Crawley
country: United Kingdom
facility: St. Catherine's Hospice
state: West Sussex
city: Leeds
country: United Kingdom
facility: St. Gemma's Hospice
state: Yorkshire
city: Leeds
country: United Kingdom
facility: Wheatfields Hospice
state: Yorkshire
city: Sheffield
country: United Kingdom
facility: St. Luke's Hospice
state: Yorkshire
Study officials:
affiliation: Consultant Palliative Medicine
name: Andrew Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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. doi: 10.1080/00365520510012208.
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. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
citation: 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.