Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT02858856
Status:
UNKNOWN
Last Update Posted:
2017-09-15
First Post:
2016-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063587', 'term': 'juzentaihoto'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2016-07-30', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Fatigue Inventory change', 'timeFrame': '0-5 week'}, {'measure': 'Brief Fatigue Inventory change', 'timeFrame': '6-11 week'}], 'secondaryOutcomes': [{'measure': 'EORTC-QLQ-C30 change', 'timeFrame': '0-5 week, 6-11 week'}, {'measure': 'EORTC-QLQ-BR23 change', 'timeFrame': '0-5 week, 6-11 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29982213', 'type': 'DERIVED', 'citation': 'Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged over 18 years\n* patients who have histologically or cytologically confirmed breast tumor\n* patients who applicable AC(doxorubicin + cyclophosphamide)\n* ECOG score 0 to 2\n\nExclusion Criteria:\n\n* patient impossible to orally intake\n* patient with dementia, delirium and depression\n* patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis\n* severe liver disability (3-fold the normal high range value for ALT, AST)\n* patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,\n* severe systemic disease\n* use of other investigational products within the past 30 days\n* hypersensitivity to investigational product\n* others who are judged not to be appropriate to study'}, 'identificationModule': {'nctId': 'NCT02858856', 'briefTitle': 'Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'ISEE_2016_SJDBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'Take Sipjeondaebo-tang on 0\\~2 week, 3\\~5 week of clinical trial period, total of 4 weeks', 'interventionNames': ['Drug: Sipjeondaebo-tang']}, {'type': 'EXPERIMENTAL', 'label': 'B group', 'description': 'Take Sipjeondaebo-tang on 6\\~8 week, 9\\~11 week of clinical trial period, total of 4 weeks', 'interventionNames': ['Drug: Sipjeondaebo-tang']}], 'interventions': [{'name': 'Sipjeondaebo-tang', 'type': 'DRUG', 'otherNames': ['Deciten granule'], 'description': 'Herbal medicine which is a compound of 10 herbs.', 'armGroupLabels': ['A group', 'B group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22711', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'CHUNHOO CHEON, M.D.(DKM)', 'role': 'CONTACT', 'email': 'hreedom35@gmail.com', 'phone': '82-2-961-9278'}], 'facility': "International St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Chunhoo Cheon', 'role': 'CONTACT', 'email': 'khuksg@gmail.com', 'phone': '8229619278'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Catholic Kwandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Seong-Gyu Ko', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}