Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-04-09 @ 10:25 AM
Study NCT ID:
NCT02577393
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004941', 'term': 'Esophagitis'}], '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': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation', 'timeFrame': 'Each patient will be enrolled for a 8-9 week trial'}], 'secondaryOutcomes': [{'measure': 'Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation', 'timeFrame': 'Each patient will be enrolled for a 8-9 week trial'}, {'measure': 'Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.', 'timeFrame': 'Each patient will be enrolled for a 8-9 week trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Neoplasms', 'esophagitis', 'Prevention & Control', 'Epigallocatechin Gallate'], 'conditions': ['Lung Neoplasms', 'Esophagitis', 'Prevention & Control', 'Epigallocatechin Gallate']}, 'descriptionModule': {'briefSummary': 'The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically documented LC\n* considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer\n* age ≥18 years\n* Karnofsky ≥70\n* adequate hematologic, hepatic and renal function\n* FEV1 \\> 800 cc\n* mean esophagus dose \\>20 Gy\n\nExclusion criteria were as follows:\n\n* a known allergy or hypersensitivity to EGCG\n* pregnancy or lactation\n* prior radiation to the thorax'}, 'identificationModule': {'nctId': 'NCT02577393', 'briefTitle': 'Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'orgStudyIdInfo': {'id': 'GTEEC-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prophylactic EGCG group', 'interventionNames': ['Drug: EGCG']}, {'type': 'EXPERIMENTAL', 'label': 'therapeutic EGCG group', 'interventionNames': ['Drug: EGCG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'conventional therapy group', 'interventionNames': ['Drug: mLDG']}], 'interventions': [{'name': 'EGCG', 'type': 'DRUG', 'description': 'EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.', 'armGroupLabels': ['prophylactic EGCG group']}, {'name': 'EGCG', 'type': 'DRUG', 'description': 'EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.', 'armGroupLabels': ['therapeutic EGCG group']}, {'name': 'mLDG', 'type': 'DRUG', 'description': 'mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.', 'armGroupLabels': ['conventional therapy group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ligang Xing, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shandong Cancer Hospital and Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Han Xi Zhao', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}