Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-05 @ 7:34 PM
Study NCT ID:
NCT02771756
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life questionnaire(QOL-C30)', 'timeFrame': 'At baseline,6 weeks and 9 weeks after baseline.'}, {'measure': 'Scored Patient-Generated Subjective Global Assessment(PG-SGA)', 'timeFrame': 'At baseline'}], 'primaryOutcomes': [{'measure': 'Weight change rate', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Siderophilin change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Interleukin 1 change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'interleukin 6 change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Tumor Necrosis Factor α change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}], 'secondaryOutcomes': [{'measure': 'Change status of the Gripping Power', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Prealbumin Blood Examination change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Albumin change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Total Bilirubin change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Bilirubin Direct change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Indirect Bilirubin change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Alkaline Phosphatase change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Alanine Aminotransferase change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Aspartate Aminotransferase change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Serum Creatinine change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Urine Nitrogen change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Lymphocyte Number change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}, {'measure': 'Hemoglobin change status', 'timeFrame': '6 weeks and 9 weeks after baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Lung cancer', 'Nutritional support', 'Safety', 'Effectiveness'], 'conditions': ['Breast Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.', 'detailedDescription': 'This study is a prospective, randomized, controlled clinical trials. 300 patients were randomly divided into 2 groups for its own control study.\n\nTest group: Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g,Bid), a total of 150 people, are used for 42 days continuously.\n\nPlacebo group: Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g, Bid), a total of 150 people, are used for 42 days continuously.\n\nThe subjects were randomized to AB or BA parallely, and the two groups were given chemotherapy and nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 70 years old\n* Breast or lung cancer was diagnosed by pathology or cytology\n* ECOG score: 0-2 points\n* PG-SGA: 2-8 points, while the weight loss within 3 months less than 5%\n* The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 \\* 10\\^9/L, PLT is equal to or over 100\\* 10\\^9/L, HGB is equal to or over 90g/L\n* Bilirubin is equal to or less than 1.5 times of the normal upper limit, AP, AST, ALT is less than or equal to 2 times of normal upper limit\n* Ccr is equal to or over 50mL/min\n* Life expectancy is equal to or over 12 weeks\n\nExclusion Criteria:\n\n* Complete or incomplete intestinal obstruction\n* A severe infection or difficult to control diabetes\n* History of organ transplantation, or current use of immunosuppressive agents\n* An intervention in nutritional supplements, or a metabolic disorder\n* Parenteral nutrition must be applied\n* Alcoholism or drug addiction\n* Pregnancy or lactation, or women of childbearing age refuse contraception\n* There are potential factors that interfere with the mental, psychological, family, social or geographical and other factors of the research project\n* There are other diseases that may interfere with the results of this study, such as the second primary tumor\n* For any other reason, the researchers were unable to complete the study'}, 'identificationModule': {'nctId': 'NCT02771756', 'briefTitle': 'The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Randomized, Self Controlled Study on the Effect of Oral Supplement of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy', 'orgStudyIdInfo': {'id': 'CH-BC-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously.', 'interventionNames': ['Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang', 'Radiation: chemotherapy', 'Other: nutrition education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously.', 'interventionNames': ['Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo', 'Radiation: chemotherapy', 'Other: nutrition education']}], 'interventions': [{'name': 'zhen qishen capsule and Oral Supplement of Yuyikang', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['test group']}, {'name': 'zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo group']}, {'name': 'chemotherapy', 'type': 'RADIATION', 'armGroupLabels': ['placebo group', 'test group']}, {'name': 'nutrition education', 'type': 'OTHER', 'armGroupLabels': ['placebo group', 'test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Yuan, MD', 'role': 'CONTACT', 'email': 'Yuanpeng01@hotmail.com', 'phone': '86-10-87788528'}], 'facility': 'National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Peng Yuan, MD', 'role': 'CONTACT', 'email': 'Yuanpeng01@hotmail.com', 'phone': '00861087788528'}], 'overallOfficials': [{'name': 'Peng Yuan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Peng Yuan', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}