Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07177820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VGAIT for Chemotherapy-induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Video-Guided Acupuncture Imagery Treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility related outcomes', 'timeFrame': '8 week', 'description': 'Completion, satisfaction'}], 'secondaryOutcomes': [{'measure': 'Patient Neurotoxicity Questionnaire (PNQ)', 'timeFrame': 'baseline, 8 week', 'description': 'A tool designed to assess neurotoxic effects in patients who have undergone treatments such as chemotherapy'}, {'measure': 'Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX)', 'timeFrame': 'baseline, 8 week', 'description': 'a widely used, validated instrument that assesses the impact of neuropathy on health-related quality of life'}, {'measure': 'Brief Pain Inventory-short form (BPI-SF)', 'timeFrame': 'baseline, 8 week', 'description': "An instrument used to evaluate the severity of pain, including neuropathic pain, and the impact on the patient's daily functioning."}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (QLQ-C30) instrument', 'timeFrame': 'baseline, 8 week', 'description': 'an instrument developed to assess the quality of life in cancer patients'}, {'measure': 'MGH Acupuncture Sensation Scale (MASS)', 'timeFrame': 'after each intervention', 'description': 'scale includes 12 descriptors of sensations frequently described during acupuncture treatment'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'baseline, 8 week', 'description': 'a 13-item self-report scale which measures pain-related rumination, magnification, and helplessness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'Perform a feasibility study on imagined acupuncture treatment of Chemotherapy-induced peripheral neuropathy (CIPN)', 'detailedDescription': 'We will perform a pilot study to assess the feasibility of Video-Guided Acupuncture Imagery Treatment (VGAIT) on CIPN symptoms in patients with stage I-III breast cancer with persistent CIPN after adjuvant chemotherapy. Participants will receive 16 sessions of VGAIT over 8 weeks remotely through the zoom. Study measures will be collected at the time of study enrollment, week 4, and week 8. The primary endpoints of the study will be 1) retention to treatment; 2) satisfaction for the intervention and 3) completion of study assessments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n* have histologically confirmed stage I-III breast cancer,\n* have completed adjuvant taxane-based chemotherapy (alone or in combination), ,\n* have an Eastern Cooperative Oncology Group performance status of 0 or 1, and reported grade 1 or greater CIPN symptoms for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.\n\nExclusion Criteria:\n\n* concurrent chemotherapy (there were no limitations on time from the last paclitaxel administration),\n* having metastatic or recurrent disease,\n* history of preexisting peripheral neuropathy prior to chemotherapy,\n* uncontrolled seizure disorder,\n* unstable cardiac disease or myocardial infarction within 6 months prior to study entry, being pregnant or nursing, or having used acupuncture for CIPN within 6 months prior to study entry.'}, 'identificationModule': {'nctId': 'NCT07177820', 'briefTitle': 'VGAIT for Chemotherapy-induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Video-Guided Acupuncture Imagery Treatment in Chemotherapy-induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '25-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VGAIT', 'interventionNames': ['Other: Video-Guided Acupuncture Imagery Treatment (VGAIT)']}], 'interventions': [{'name': 'Video-Guided Acupuncture Imagery Treatment (VGAIT)', 'type': 'OTHER', 'description': 'Participants watch a video of acupuncture being applied to the body while simultaneously imagining that it is being administered to them', 'armGroupLabels': ['VGAIT']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sierra Hodges', 'role': 'CONTACT', 'email': 'sahodges@mgb.org', 'phone': '6177265004'}, {'name': 'Jian Kong', 'role': 'CONTACT', 'email': 'jkong2@mgh.harvard.edu', 'phone': '16179620978'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian Kong', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}