Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04076033
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Reproducibility of Bandaging in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008209', 'term': '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': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '2 minutes', 'description': 'mmHg'}], 'secondaryOutcomes': [{'measure': 'Blood flow', 'timeFrame': '10 minutes', 'description': 'mL/s'}, {'measure': 'Jebsen Taylor test', 'timeFrame': '10 minutes', 'description': 'time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Compressive Bandage', 'Lymphedema', 'Physiotherapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Functional Compressive Bandage (ECF) is a widely used therapeutic resource in the control of lymphedema resulting from the treatment of breast cancer, however, the effects inherent to the technique depend on the quality of the application. The aim of the study is to evaluate the reliability, reproducibility, and efficiency of treatment with different techniques in two studies. The first step aims to evaluate the reliability and reproducibility of the technique. The analysis of the pressure exerted by the four-layer bandage, applied by two evaluators previously trained and familiar with the ECF technique will perform the evaluations on the same volunteers in two moments, with an interval of one week between them. The intraclass correlation coefficient will be used to determine intra- and inter-examiner reliability, with its respective 95% confidence interval, standard error of measurement and minimum detectable change. The second stage aims to verify the efficiency of different ECF techniques in the functionality and circulation of the upper limb affected by lymphedema. This step is being performed by a single evaluator, and the ECF efficiency tested by the random application of two different techniques (spiral and eight), with a seven-day interval, and pressure assessment in mmHg. Upper limb functionality analysis is being performed using the Jebsen Taylor test performed before and with ECF on both limbs. The evaluation of the influence of the bandage in the circulation evaluated by Doppler ultrasound, before and after the test application. Member dominance assessed using the Edinburgh inventory.', 'detailedDescription': 'Functional Compressive Bandage (ECF) is a widely used therapeutic resource in the control of lymphedema resulting from the treatment of breast cancer, however, the effects inherent to the technique depend on the quality of the application. The aim of the study is to evaluate the reliability, reproducibility, and efficiency of treatment with different techniques in two studies. To this end, 50 volunteers will be evaluated, aged between 40 and 70 years, submitted to breast cancer treatment. The analyzes will be performed in two subprojects, conducted with randomized cross over design and seven days wash out period, so far 19 volunteers were collected. The first step aims to evaluate the reliability and reproducibility of the technique. The analysis of the pressure exerted by the four-layer bandage, applied by two evaluators previously trained and familiar with the ECF technique will perform the evaluations on the same volunteers in two moments, with an interval of one week between them. The intraclass correlation coefficient (ICC2,1) will be used to determine intra- and inter-examiner reliability, with its respective 95% confidence interval, standard measurement error and minimum detectable change. The second stage aims to verify the efficiency of different ECF techniques in the functionality and circulation of the upper limb affected by lymphedema. This step is being performed by a single evaluator, and the ECF efficiency tested by the random application of two different techniques (spiral and eight), with a seven-day interval, and pressure assessment in mmHg. Upper limb functionality analysis is being performed using the Jebsen Taylor test performed before and with ECF on both limbs. The evaluation of the influence of the bandage in the circulation evaluated by Doppler ultrasound, before and after the test application. Member dominance assessed using the Edinburgh inventory. Partial data was verified by descriptive analysis with mean and standard deviation. Data processing was performed using SPSS® software, version 13.0 (Chicago, IL, USA). A significance level of 5% was considered. The information obtained in the study aims to show the partial results of the preliminary and descriptive evaluation of the physical therapy intervention in women affected by lymphedema resulting from breast cancer treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria are age over 21 years, treatment for unilateral breast cancer, unilateral lymphedema resulting from treatment for breast cancer.\n\nExclusion Criteria:\n\n* The exclusion criteria established are skin disorders; diabetes; adjuvant treatment in progress; submitted to bilateral axillary dissection; diagnosis of metastasis and at risk of peripheral arterial disease, functional change of upper limbs before breast cancer treatment.'}, 'identificationModule': {'nctId': 'NCT04076033', 'briefTitle': 'Reliability and Reproducibility of Bandaging in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Reliability, Reproducibility, and Efficiency of Functional Compressive Assessment in the Treatment of Secondary Lymphedema to the Treatment of Breast Cancer', 'orgStudyIdInfo': {'id': '000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECF ESPIRAL', 'description': "The volunteer is submitted to four-layer spiral functional compressive bandage, then performs Taylor's Jebsen manual function test with comprehensive functional bandage (ECF).", 'interventionNames': ['Other: functional compressive bandage']}, {'type': 'EXPERIMENTAL', 'label': 'ECF OITO', 'description': 'The volunteer is submitted to functional compressive bandage in eight with four layers, then performs the Taylor Jebsen manual function test with the comprehensive functional bandage (ECF).', 'interventionNames': ['Other: functional compressive bandage']}], 'interventions': [{'name': 'functional compressive bandage', 'type': 'OTHER', 'description': 'The functional compressive bandage is being performed with the volunteer sitting with the upper limb homolateral to the surgery supported by a support. After hydration of the limb, a cotton mesh is being used to prevent friction of the 1 cm density foam band being wrapped around the limb. No therapeutic procedure is being performed prior to functional compressive bandage.\n\nThe bandage of the limb is being performed with 5 cm, 10 cm, 15 cm elastic cotton bandages from the fingers to the axillary region in four layers.', 'armGroupLabels': ['ECF ESPIRAL', 'ECF OITO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Elaine Caldeira de Oliveira Guirro, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elaine Caldeira de Oliveira Guirro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Elaine Caldeira de Oliveira Guirro', 'investigatorAffiliation': 'University of Sao Paulo'}}}}