Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-05 @ 1:38 PM
Study NCT ID:
NCT06495034
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of lymphedema', 'timeFrame': '18 months', 'description': 'Incidence of lymphedema of ipsilateral upper limb'}], 'secondaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': '18 months', 'description': 'Questionnaire. The level of subjective symptoms( pain, heaviness, paresthesia) at each time point was recorded with a 0-3 four-point scale questionnaire. 0-3 indicated no symptoms, mild, moderate, and severe, respectively.'}, {'measure': 'Quality of life assessment', 'timeFrame': '18 months', 'description': 'FACT-B (V4.0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer-related lymphedema', 'airwave compression therapy', 'quality of life'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).', 'detailedDescription': 'This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;\n* Female, ≥18 years old and ≤70 years old at the time of signing the ICF;\n* Patients with unilateral breast cancer diagnosed by histopathology or cytology;\n* No distant metastasis;\n* To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;\n* Have not received any treatment for arm lymphedema;\n* No lymphangitis and other infections.\n\nExclusion Criteria:\n\n* Breast malignancy derived from other tumors rather than the primary breast cancer;\n* Patients with second primary tumor;\n* Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;\n* Have a history of mental illness or other reasons can not cooperate with treatment;\n* Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;\n* Patients using any medication that affects fluid or electrolyte balance.'}, 'identificationModule': {'nctId': 'NCT06495034', 'briefTitle': 'Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Shantou Central Hospital'}, 'officialTitle': 'A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema', 'orgStudyIdInfo': {'id': 'ShantouCH003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'standard care: health education and routine functional exercise', 'interventionNames': ['Other: standard care: health education and routine functional exercise']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': '1. standard care: health education and routine functional exercise;\n2. airwave compression therapy', 'interventionNames': ['Device: airwave compression therapy', 'Other: standard care: health education and routine functional exercise']}], 'interventions': [{'name': 'airwave compression therapy', 'type': 'DEVICE', 'otherNames': ['Airwave pressure therapy，intermittent pneumatic compression pump，IPC'], 'description': 'Airwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb', 'armGroupLabels': ['experimental group']}, {'name': 'standard care: health education and routine functional exercise', 'type': 'OTHER', 'description': 'standard care: health education and routine functional exercise', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wan-Lin Zhan, Dr.', 'role': 'CONTACT', 'email': '287822522@qq.com', 'phone': '008619830233390'}], 'facility': 'Shantou Central Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'centralContacts': [{'name': 'Zhi-Yong Wu, Dr.', 'role': 'CONTACT', 'email': 'stwzy@163.com', 'phone': '008613502953050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shantou Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Si-Qi Qiu', 'investigatorAffiliation': 'Shantou Central Hospital'}}}}