Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT02663492
Status:
UNKNOWN
Last Update Posted:
2016-01-26
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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': ['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': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Blood routine indexes in 1 month', 'timeFrame': 'Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28', 'description': 'The routine blood examinations of indicators of bone marrow suppression, including red blood cells (10\\^12/L), hemoglobin (g/L), white blood cells (10\\^9/L), and platelets (10\\^9/L).'}], 'secondaryOutcomes': [{'measure': 'Change of Comfort Degree', 'timeFrame': 'Day 0, Day 8, and Day 28', 'description': "The Comfort Scale is assessed using General Comfort Questionnaire designed by KY Kolcaba. A preliminary experiment was conducted in 30 patients with NSCLC before the first visit, and the reliability coefficient of the scale was calculated; Cronbach's alpha = 0.932 indicated high internal consistency."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acupuncture', 'electrical stimulation of acupoints', 'chemotherapy', 'Diyu Shengbai Pian', 'nursing care'], 'conditions': ['Non-Small Cell Lung Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.', 'detailedDescription': 'Lung cancer is the malignant neoplasm with the highest incidence and mortality in China as well as worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Chemotherapy is the preferred treatment method for NSCLC, but many patients cannot tolerate the adverse reactions of chemotherapy. Among the most common and most severe adverse reactions is bone marrow suppression. The more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. Literatures showed Acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. In this study, the effect of percutaneous electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of Non-small cell lung cancer(NSCLC)\n* age between 20 and 75 years\n* chemotherapy naive after diagnosis\n* GP regimen as treatment\n* an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on Karnofsky performance status (KPS) scale\n* the ability to understand and speak Mandarin\n\nExclusion Criteria:\n\n* diagnosis of a hematological system tumor\n* mental illness\n* bone marrow suppression prior to chemotherapy\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02663492', 'briefTitle': 'Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tongji University'}, 'officialTitle': 'Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'TEAS_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEAS group', 'description': 'Patients with transcutaneous electrical acupoint stimulation (TEAS) group receive electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4).', 'interventionNames': ['Device: TEAS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medication group', 'description': 'On the basis of routine nursing care, patients need to take Sanguisorba officinalis L., named Diyu Shengbai Pian (a Traditional Chinese Medicine) 3 times per day.', 'interventionNames': ['Drug: Sanguisorba officinalis L.']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The patients of control group receive routine nursing care, including (1) to be observed the changes in patient condition, (2) to eat high-calories, high-protein, high-vitamin, easy-to-digest foods during chemotherapy, (3) to be treated by psychological care, (4) to be prevented against the occurrence of phlebiti, and (5) to use Ondansetron and Omeprazole as direction.'}], 'interventions': [{'name': 'TEAS', 'type': 'DEVICE', 'description': 'The patients will be treated by their assigned acupuncture stimulation in 7 days. The surface electrical stimulation devices and application parameter are: G6805-II pulse acupuncture treatment instrument from Shanghai Medical Technology Company, Ltd (Shanghai, China); sparse-dense wave stimulation (sparse wave 30Hz; dense wave 100Hz) with an intensity of 6-15 V; and the corresponding parts of the body experienced a slight quiver, with a duration 20 minutes each time.', 'armGroupLabels': ['TEAS group']}, {'name': 'Sanguisorba officinalis L.', 'type': 'DRUG', 'otherNames': ['Diyu Shengbai Pian'], 'description': 'Sanguisorba officinalis L., a Leukogenic medication, named Diyu Shengbai Pian (Chengdu Diao Tianfu Pharmaceutical Group Co., Ltd., China) will be taken 0.4g each time by 3 times per day.', 'armGroupLabels': ['Medication group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Xu, MD', 'role': 'CONTACT', 'email': 'xuying2186@hotmail.com', 'phone': '86-21-65115006', 'phoneExt': '1053'}, {'name': 'Di Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital Medical Oncology Department', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lili Hou, Master', 'role': 'CONTACT', 'email': 'qing_0_122@163.com', 'phone': '8613816033620'}], 'overallOfficials': [{'name': 'Caicun Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pulmonary Hospital of Tongji University, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Caicun Zhou', 'investigatorAffiliation': 'Tongji University'}}}}