Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-03-09 @ 6:05 AM
Study NCT ID:
NCT02603016
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2015-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-11', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T-lymphocyte cell subsets', 'timeFrame': 'three mouths', 'description': 'T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clinical Nutrition'], 'conditions': ['Lung Neoplasms', 'Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma', 'detailedDescription': 'GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* lung cancer and breast cancer patients confirmed by surgery pathology;\n* ECOG physical stamina score of 0\\~3 points;\n* Expected lifetime \\> 3 months;\n* Need to receive radiation and chemotherapy;\n* Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;\n* To follow-up, good adherence\n\nExclusion Criteria:\n\n* Allergic to text drug;\n* Pregnancy or lactation women;\n* Suffering from mental illness of not easy to control,\n* Have serious mental or cognitive dysfunction;\n* Can not comply with the experimental scheme or can't cooperate with the follow-up;\n* The patients who are unfavorable to the subject."}, 'identificationModule': {'nctId': 'NCT02603016', 'briefTitle': 'Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma', 'orgStudyIdInfo': {'id': 'PLAGHS201503601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLSE compound group', 'description': 'GLSE compound 2g each time by mouth,twice a day for 42 days.', 'interventionNames': ['Drug: GLSE compound']}, {'type': 'EXPERIMENTAL', 'label': 'Maitake mushroom extract compound group', 'description': 'Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.', 'interventionNames': ['Drug: Maitake mushroom extract compound']}, {'type': 'EXPERIMENTAL', 'label': 'Ginseng compound group', 'description': 'Ginseng compound 2 tables each time by mouth,twice a day for 42 days.', 'interventionNames': ['Drug: Ginseng compound']}, {'type': 'NO_INTERVENTION', 'label': 'blank control group', 'description': 'Take nothing.'}], 'interventions': [{'name': 'GLSE compound', 'type': 'DRUG', 'armGroupLabels': ['GLSE compound group']}, {'name': 'Maitake mushroom extract compound', 'type': 'DRUG', 'armGroupLabels': ['Maitake mushroom extract compound group']}, {'name': 'Ginseng compound', 'type': 'DRUG', 'armGroupLabels': ['Ginseng compound group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Shunchang Jiao, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician', 'investigatorFullName': 'Zhiyong Wu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}