Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02707835
Status:
UNKNOWN
Last Update Posted:
2016-03-17
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D004487', 'term': 'Edema'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thickness of epidermis and dermis', 'timeFrame': '10 mins'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Edema,taping,ultrasound'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.\n\nThe purpose of this study is to investigate\n\n1. The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.\n2. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.\n\nOur hypothesis :\n\n1. The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.\n2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. age:20\\~80 y/o\n2. female patients with unilateral breast cancer after surgery\n3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound sideļ¼\n4. do not receive any treatment of lymph edema Exclusion criteria\n\n1\\. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant'}, 'identificationModule': {'nctId': 'NCT02707835', 'briefTitle': 'Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effect of Edema Control in Patients With Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping With Ultrasonography', 'orgStudyIdInfo': {'id': '201505100RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'self massage, skin care education, manual lymph drainage exercise, compression garment', 'interventionNames': ['Other: self massage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'manual lymph drainage group', 'description': 'manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment', 'interventionNames': ['Other: manual lymph drainage']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment', 'interventionNames': ['Other: epidermis fascia taping']}], 'interventions': [{'name': 'self massage', 'type': 'OTHER', 'description': 'self massage, skin care education, manual lymph drainage exercise, compression garment', 'armGroupLabels': ['control group']}, {'name': 'manual lymph drainage', 'type': 'OTHER', 'description': 'manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment', 'armGroupLabels': ['manual lymph drainage group']}, {'name': 'epidermis fascia taping', 'type': 'OTHER', 'description': 'epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jing-Lan Yang', 'role': 'CONTACT', 'email': 'yangjinglan@gmail.com', 'phone': '886-2-23123456-67564'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jing-Lan Yang', 'role': 'CONTACT', 'email': 'yangjinglan@gmail.com', 'phone': '886-2-23123456-67564'}, {'name': 'SHU-FEN WANG, PhD', 'role': 'CONTACT', 'email': 'shwufenwang@gmail.com', 'phone': '886-972651068'}], 'overallOfficials': [{'name': 'Jing-Lan Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}