Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-25 @ 11:59 PM
Study NCT ID:
NCT02469493
Status:
UNKNOWN
Last Update Posted:
2015-06-22
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-06-18', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neuroimaging data', 'timeFrame': '24 hours'}], 'primaryOutcomes': [{'measure': 'The scores of Rhodes Index of Nausea, Vomiting and Retching.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Content of 5-hiaa in urine', 'timeFrame': '12 hours'}, {'measure': 'Heart Rate Variability', 'timeFrame': '1 hour'}, {'measure': 'Tachygastria percentage', 'timeFrame': '1 hour'}, {'measure': 'Dosage of antiemetic drugs', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;\n* Right-handed and aged 18 to 75 years;\n* Karnosky performance status (KPS) ≥ 70;\n* Life expectancy ≥ 6 months.\n\nExclusion Criteria:\n\n* Had brain metastases or other concurrent life-threatening diseases;\n* Nausea and/or vomiting were present 24h before chemotherapy treatment;\n* Suffered from or had a history of gastrointestinal diseases;\n* Had a history of head trauma, serious neurological or psychiatric disorders;\n* Participating in other clinical trials currently;\n* Had any contraindication to exposure to a high magnetic field or receive acupuncture'}, 'identificationModule': {'nctId': 'NCT02469493', 'briefTitle': 'The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Xidian University'}, 'orgStudyIdInfo': {'id': '2014CB543203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture 1', 'description': 'In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.', 'interventionNames': ['Device: acupuncture (Huatuo)']}, {'type': 'EXPERIMENTAL', 'label': 'Acupuncture 2', 'description': 'In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.', 'interventionNames': ['Device: acupuncture (Huatuo)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture', 'description': 'In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.', 'interventionNames': ['Device: acupuncture (Huatuo)']}, {'type': 'NO_INTERVENTION', 'label': 'Waitinglist control', 'description': 'In this group, patients received no electroacupuncture'}], 'interventions': [{'name': 'acupuncture (Huatuo)', 'type': 'DEVICE', 'description': 'The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25\\*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.', 'armGroupLabels': ['Acupuncture 1', 'Acupuncture 2', 'Sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang', 'role': 'CONTACT', 'phone': '86(029)-84775343'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jin, Doctor', 'role': 'CONTACT', 'email': 'king-jlm@163.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xidian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wei Qin', 'investigatorAffiliation': 'Xidian University'}}}}