Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 11:04 PM
Study NCT ID:
NCT05434403
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-26', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day0', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day3', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day5', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day8', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day14', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day30', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day60', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}, {'measure': 'NRS(numerical rating scale)', 'timeFrame': 'Day90', 'description': '0-10，0 =no pain, 10 = the most severe pain.'}], 'secondaryOutcomes': [{'measure': 'NCI-CTC v4.0 neurotoxicity classification', 'timeFrame': 'Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90', 'description': 'Assess the degree of motor neurotoxicity and sensory neurotoxicity'}, {'measure': 'QST( Quantitative Sensory Testing)', 'timeFrame': 'Day1,Day14', 'description': 'left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,'}, {'measure': 'IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α', 'timeFrame': 'Day1,Day14', 'description': 'Hematological examination to test the concentration of IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α'}, {'measure': 'Athens insomnia scale', 'timeFrame': 'Day1,Day8,Day14,Day30,Day60,Day90', 'description': '\\<4 No sleep disorder,4-6=Suspicious insomnia,\\>6=Insomnia'}, {'measure': 'SF-12，Short From health survey -12', 'timeFrame': 'Day1,Day8,Day14,Day30,Day60,Day90', 'description': 'Calculate the Physical Component Summary (PCS) and\n\nMental Component Summary (MCS).The higher the score, the worse the quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CIPN', 'Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is currently receiving chemotherapy drugs with neurotoxicity\n2. New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms\n\nExclusion Criteria:\n\n1. Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.\n2. Patients taking analgesics due to pain in other parts of the body.'}, 'identificationModule': {'nctId': 'NCT05434403', 'briefTitle': 'Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2022PHB107-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham stimulation group', 'interventionNames': ['Device: sham vagus nerve stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'stimulation group', 'interventionNames': ['Device: Vagus nerve stimulation']}], 'interventions': [{'name': 'Vagus nerve stimulation', 'type': 'DEVICE', 'description': 'vagus nerve electrical stimulation through ear skin', 'armGroupLabels': ['stimulation group']}, {'name': 'sham vagus nerve stimulation', 'type': 'DEVICE', 'description': 'sham vagus nerve electrical stimulation through ear skin', 'armGroupLabels': ['Sham stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "People's Hospital of Peking University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yi Feng, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of department of Anesthesiology and Pain medicine', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}