Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT01399294
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross Sectional Study of Constipation in Advanced Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TCM syndrome distribution', 'timeFrame': 'End of recruitment (estimated timeframe: 3 months)', 'description': 'Five TCM syndromes, i.e. Excess Heat, Qi Stagnation, Qi Deficiency, Yang Deficiency and Yin Deficiency, are differentiated by TCM practitioner.'}], 'secondaryOutcomes': [{'measure': 'bowel habit', 'timeFrame': 'End of recruitment (estimated timeframe: 3 months)', 'description': "1. Patient's own reporting or experience of constipation\n2. Effectiveness of current practice in relief of constipation"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Palliative Care', 'Advanced Cancer', 'Constipation', 'Traditional Chinese Medicine', 'Syndrome Distribution'], 'conditions': ['Palliative Care', 'Constipation', 'Traditional Chinese Medicine']}, 'descriptionModule': {'briefSummary': 'Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients.\n\nTraditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. More than half had received at least one form of TCM therapy according to the survey carried in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients.\n\nTCM syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.\n\nThe present study is the first local study to evaluate the bowel habits and TCM syndrome of advanced cancer patients with constipation. We hope that the results not only can shed light on patient\'s own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a CHM formulation for advanced cancer patients with constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced cancer patients (aged 18 or above) under the care of palliative care units who are on laxatives and who have constipation during recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced cancer patients\n* on medication for facilitating bowel movement and/or constipation visual analogue scale \\>=2\n\nExclusion Criteria:\n\n* unable to communicate\n* cognitive impaired\n* put on colostomy bag\n* clinically diagnosed gastrointestinal obstruction\n* at end-of-life'}, 'identificationModule': {'nctId': 'NCT01399294', 'briefTitle': 'Cross Sectional Study of Constipation in Advanced Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yan Chai Hospital'}, 'officialTitle': 'Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation', 'orgStudyIdInfo': {'id': 'Constipation/TCM2010'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Caritas Medical Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Our Lady of Maryknoll Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Doris MW Tse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine & Geriatrics / ICU, Caritas Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yan Chai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Tse Man Wah, Doris / Chief of Service', 'oldOrganization': 'Department of Medicine & Geriatrics / ICU, Caritas Medical Centre'}}}}