Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 10:31 AM
Study NCT ID:
NCT04404933
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2020-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Opioid-Induced Constipation 2 Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of OIC', 'timeFrame': '28 days', 'description': 'BFI \\< 30'}], 'secondaryOutcomes': [{'measure': 'Improvement in BFI', 'timeFrame': '28 days', 'description': 'BFI improved by 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid-induced constipation'], 'conditions': ['Opioid-induced Constipation', 'Cancer', 'Cancer Pain']}, 'referencesModule': {'references': [{'pmid': '31396746', 'type': 'RESULT', '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.'}, {'pmid': '19912069', 'type': 'RESULT', '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.'}, {'pmid': '26582720', 'type': 'RESULT', '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.'}, {'pmid': '16036506', 'type': 'RESULT', '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.'}, {'pmid': '10964347', 'type': 'RESULT', '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.'}, {'pmid': '34348942', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer.\n\nThe 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.', 'detailedDescription': '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.\n\nPatients 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.\n\nStep 1: Conventional Laxatives\n\n* Choice of laxatives at the discretion of the clinical team\n* Combination of softener and stimulant laxative\n* Laxatives to be prescribed on a regular basis\n\nStep 2: Peripherally acting mu opioid receptor antagonist (PAMORA)\n\n* Choice of PAMORA at the discretion of clinical team\n* Either oral naloxegol or subcutaneous methylnaltrexone\n* PAMORA to be prescribed on a regular basis\n\nStep 3: PAMORA + Conventional Laxatives\n\n* Choice of combination at the discretion of the PI/clinical team\n* Combination to be prescribed on a regular basis\n\nStep 4: Other options\n\n\\- Choice of other option at discretion of clinical team:\n\n* Bowel cleansing preparations (e.g. Picolax)\n* Suppositories\n* Enemas\n* Manual evacuation\n* Other drugs (e.g. lubiprostone, prucalopride)\n\nThe 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.\n\nThe participants will also be asked to complete;\n\n1. 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.\n2. 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.\n3. 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.\n\nData will also be collected on adverse effects from medication / interventions, and reasons for withdrawal from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants may be inpatients, outpatients, day centre patients and home care patients at the sites conducting the research', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* As per StOIC 1: age \\> 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week\n* Diagnosis of OIC as defined by the Rome IV criteria (Lacy et al, 2016)\n* Diagnosis of inadequately treated OIC as defined by BFI \\> 30\n\nExclusion Criteria:\n\n* As per StOIC 1: inability to give informed consent; inability yo complete questionnaire\n* Prognosis \\> 1 month'}, 'identificationModule': {'nctId': 'NCT04404933', 'acronym': 'StOIC-2', 'briefTitle': 'Study of Opioid-Induced Constipation 2 Project', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain', 'orgStudyIdInfo': {'id': 'StOIC-2 Project'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment algorithm for OIC', 'type': 'OTHER', 'description': 'Treatment Algorithm for OIC'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LQ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Brighton & Sussex University Hospitals', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'GL53 0QJ', 'city': 'Cheltenham', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Leckhampton Court Hospice', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'HP43GW', 'city': 'Berkhamstead', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'Hospice of St. Francis', 'geoPoint': {'lat': 51.7604, 'lon': -0.56528}}, {'zip': 'ME20 7PU', 'city': 'Maidstone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Heart of Kent Hospice', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'ME1 2NU', 'city': 'Rochester', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Wisdom Hospice', 'geoPoint': {'lat': 51.38764, 'lon': 0.50546}}, {'zip': 'SM3 9DX', 'city': 'Cheam', 'state': 'London', 'country': 'United Kingdom', 'facility': "St. Raphael's Hospice", 'geoPoint': {'lat': 51.36179, 'lon': -0.21977}}, {'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'BA20 2HU', 'city': 'Yeovil', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': "St Margaret's Hospice", 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}, {'zip': 'WS14 9LH', 'city': 'Lichfield', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'St. Giles Hospice', 'geoPoint': {'lat': 52.68154, 'lon': -1.82549}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'B29 7DA', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': "Birmingham St. Mary's Hospice", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'RH10 6BH', 'city': 'Crawley', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': "St. Catherine's Hospice", 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}, {'zip': 'LS17 6QD', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': "St. Gemma's Hospice", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LS6 2AE', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Wheatfields Hospice', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'S11 9NE', 'city': 'Sheffield', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': "St. Luke's Hospice", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Andrew Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Palliative Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, there are no plans to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyowa Hakko Kirin UK, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}