Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT02737735
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2016-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-09', 'studyFirstSubmitDate': '2016-03-26', 'studyFirstSubmitQcDate': '2016-04-09', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life Questionnaire (EORTC QLQ C30)scores', 'timeFrame': '36months'}, {'measure': 'RECIST(Response Evaluation Criteria In Solid Tumors)', 'timeFrame': '36months'}, {'measure': 'KPS scores', 'timeFrame': '36months'}, {'measure': 'nutritional evaluation scores', 'timeFrame': '36months'}, {'measure': 'BMS(Bone marrow suppression) scores', 'timeFrame': '36months'}, {'measure': 'Gastrointestinal reactions scores', 'timeFrame': '36months'}, {'measure': 'hair loss level scores', 'timeFrame': '36months'}, {'measure': 'AST value', 'timeFrame': '36months'}, {'measure': 'ALT value', 'timeFrame': '36months'}, {'measure': 'creatinine value', 'timeFrame': '36months'}], 'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': '36months'}, {'measure': 'progression-free survival rate', 'timeFrame': '36months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age \\> 18 ages\n* Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.\n* White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L\n* ALT, AST, normal or less than 2 times, bilirubin is normal\n* Serum level in the normal range;Thr ecg is normal\n* Expected survival time≥ 3 months or more;\n* Agreed to the treatment combined traditional Chinese medicine with western medicine\n\nExclusion Criteria:\n\n* Engaged in other clinical subjects\n* Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail\n* Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor\n* Severe damage of heart, liver and kidney (cardiac function grade 3 \\~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)\n* Mental illness, Refused to partner; Cannot obtain informed consent'}, 'identificationModule': {'nctId': 'NCT02737735', 'briefTitle': 'The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': 'SBao-guo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy combined with compound herbal medicine', 'description': 'Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis.', 'interventionNames': ['Drug: standard chemotherapy medicine combined with Chinese herbs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks', 'interventionNames': ['Drug: standard chemotherapy medicine']}], 'interventions': [{'name': 'standard chemotherapy medicine combined with Chinese herbs', 'type': 'DRUG', 'armGroupLabels': ['Chemotherapy combined with compound herbal medicine']}, {'name': 'standard chemotherapy medicine', 'type': 'DRUG', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bao-guo Sun, doctor', 'role': 'CONTACT', 'email': 'Sunbaoguo666@126.com', 'phone': '13316134352'}], 'facility': 'The First Affiliated Hospital of Sun-yat Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Bao-guo Sun, doctor', 'role': 'CONTACT', 'email': 'Sunbaoguo666@126.com', 'phone': '13316134352'}, {'name': 'Xin Zhou, master', 'role': 'CONTACT', 'email': 'myeva520@163.com', 'phone': '13533259616'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sun Bao-guo', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}