Clinical trial NCT04350112: Study of Opioid-Induced Constipation 1 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: 2020-04-16
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 subjects that are either inpatients or outpatients at study sites (hospitals and hospices in the United Kingdom)

Brief summary: The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

Detailed description: StOIC-1 is an observational study, and will involve a single visit (see below for schedule).

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; e) other medications; f) Eastern Co-operative Oncology Group performance status

The participants will be asked the following questions:

1. Simple question - "Are you constipated?" \[Options - yes / no / unsure\]
2. European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' \[Options - yes / no / unsure\]
3. Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' \[Options - yes / no / unsure
4. Rome IV diagnostic criteria for OIC

The participants will also be asked to complete:

1. Bowel function index (BFI). 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). 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). The MSAS-SF is a validated, 32 item, patient-reported tool for assessing physical and psychological symptoms in cancer patients.

The participant will also undergo a palliative care specialist assessment for constipation / OIC. The palliative care specialist will be asked to review the patient with regard to their bowel function, and then asked the following questions: a) does the patient have constipation? \[Options - yes / no / unsure\]; b) (if appropriate) does the patient have opioid-induced constipation? \[Options - yes / no / unsure\]; c) (if appropriate) does the patient have additional causes of constipation? \[Options - yes / no / unsure\]; d) (if appropriate) what additional causes of constipation?I

Eligibility criteria: Inclusion Criteria:

* Age \> 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week

Exclusion Criteria:

* Inability to give informed consent; inability to complete questionnaire

Primary outcomes:
measure: Prevalence of opioid-induced constipation
timeFrame: 1 week
Secondary outcomes:
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 N Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.
citation: Larkin PJ, Sykes NP, Centeno C, Ellershaw JE, Elsner F, Eugene B, Gootjes JR, Nabal M, Noguera A, Ripamonti C, Zucco F, Zuurmond WW; European Consensus Group on Constipation in Palliative Care. The management of constipation in palliative care: clinical practice recommendations. Palliat Med. 2008 Oct;22(7):796-807. doi: 10.1177/0269216308096908.
citation: Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
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: 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: 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: 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: Ueberall MA, Muller-Lissner S, Buschmann-Kramm C, Bosse B. The Bowel Function Index for evaluating constipation in pain patients: definition of a reference range for a non-constipated population of pain patients. J Int Med Res. 2011;39(1):41-50. doi: 10.1177/147323001103900106.