Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06074718
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (ORR)', 'timeFrame': '3 years', 'description': 'Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1'}], 'secondaryOutcomes': [{'measure': 'progression free survival (PFS),', 'timeFrame': '5 years', 'description': "Evaluate subjects' progression free survival (PFS), overall survival (OS), and duration of remission (DOR) based on RECIST V1.1"}, {'measure': 'overall survival (OS)', 'timeFrame': '5 years', 'description': "Evaluate subjects' overall survival (OS) based on RECIST V1.1"}, {'measure': 'duration of remission (DOR)', 'timeFrame': '5 years', 'description': "Evaluate subjects' duration of remission (DOR) based on RECIST V1.1"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spleen deficiency and dampness obstructed', 'cancer'], 'conditions': ['Pricking Therapy on the Back Shu Points', 'Wheat Grain Moxibustion on the Back Shu Points']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;\n* Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;\n* Good compliance and signed informed consent form.\n\nExclusion Criteria:\n\n* Patients who cannot lie prone for a long time;\n* Pregnant women;\n* Lactating women'}, 'identificationModule': {'nctId': 'NCT06074718', 'briefTitle': 'Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer', 'organization': {'class': 'OTHER', 'fullName': "Jiangsu Taizhou People's Hospital"}, 'officialTitle': 'Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type', 'orgStudyIdInfo': {'id': 'JiangsuTaizhouPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pricking therapy and wheat grain moxibustion combined with chemotherapy', 'description': 'pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points combined with chemotherapy', 'interventionNames': ['Other: pricking therapy and wheat grain moxibustion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chemotherapy', 'description': 'Conventional chemotherapy regimen', 'interventionNames': ['Other: pricking therapy and wheat grain moxibustion']}], 'interventions': [{'name': 'pricking therapy and wheat grain moxibustion', 'type': 'OTHER', 'description': 'pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points', 'armGroupLabels': ['chemotherapy', 'pricking therapy and wheat grain moxibustion combined with chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225300', 'city': 'Taizhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingtao Ni', 'role': 'CONTACT', 'email': 'nqt1990@126.com', 'phone': '18852656280'}], 'facility': 'Qingtao Ni', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}], 'centralContacts': [{'name': 'Qingtao Ni', 'role': 'CONTACT', 'email': 'nqt1990@126.com', 'phone': '18852656280'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Jiangsu Taizhou People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director, Project Management Department, Centre for Clinical Research', 'investigatorFullName': 'niqingtao', 'investigatorAffiliation': "Jiangsu Taizhou People's Hospital"}}}}