Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT03051750
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Techniques for Breast Cancer-Related Lymphedema.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '3-month previous washout period; 3-week treatment phases; 3-month washout period between both treatment phases.\n\nOpen design: it is impossible during the treatment to blind the physiotherapists and patients, due to the observable differences between both therapies both during their application and in the hours after their removal, by the marks that leave in the skin.\n\nInterventions: The two therapies compared are:\n\n* CPT+ P.\n* KT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Years old at the beginning of the study.'}, {'measure': 'Time since axillary surgery.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Time since axillary surgery in years at the beginning of the study.'}, {'measure': 'Type of axillary surgery.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Lymphadenectomy or Sentinel Lymph Node Biopsy.'}, {'measure': 'Type of breast surgery.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Lumpectomy or mastectomy.'}, {'measure': 'Radiotherapy for Breast Cancer.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Yes or not.'}, {'measure': 'Time since the appearance of the BCRL.', 'timeFrame': 'First day of treatment of the first phase.', 'description': 'Years since the BCRL appeared.'}], 'primaryOutcomes': [{'measure': 'Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'Truncated Cone Formula for Volume from upper limb circumference.'}], 'secondaryOutcomes': [{'measure': 'Score on the DASH Outcome Measure.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'Validated questionnaire about Disability of the Arm,Shoulder and Hand.'}, {'measure': 'Score of the TTDL questionnaire.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'a quality of life questionnaire for patients with breast cancer-related upper lymphedema using textile therapeutic device validated previously (not yet published).'}, {'measure': 'Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'Wong-Baker faces pain rating scale.'}, {'measure': 'Stage of the lymphedema.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'I, IIA, IIB III, IV.'}, {'measure': 'Goniometry of Upper Limb.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'Goniometry of shoulder, elbow and wrist.'}, {'measure': 'Body Mass Index.', 'timeFrame': 'Four weeks during each treatment phase', 'description': 'The weight in kilograms divided by the square of the height in metres (kg/m2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer-Related Lymphedema', 'Complex Physical Therapy', 'Pressotherapy', 'Kinesio Taping', 'Physiotherapy', 'Manual Lymph Drainage', 'Multilayer Bandage', 'TTDL questionnaire'], 'conditions': ['Breast Cancer Lymphedema']}, 'referencesModule': {'references': [{'pmid': '35642305', 'type': 'DERIVED', 'citation': 'Pajero Otero V, Garcia Delgado E, Martin Cortijo C, Rodriguez Ramos ML, De Carlos Iriarte E, Gil Garcia A, Romay-Barrero H, Avendano-Coy J. Intensive complex physical therapy combined with intermittent pneumatic compression versus Kinesio taping for treating breast cancer-related lymphedema of the upper limb: A randomised cross-over clinical trial. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13625. doi: 10.1111/ecc.13625. Epub 2022 May 31.'}]}, 'descriptionModule': {'briefSummary': 'This crossover study compares two different treatment techniques for Breast Cancer-Related Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.\n\n2\\. Kinesio Taping.', 'detailedDescription': 'Breast Cancer-Related Lymphedema (BCRL) tends to progress in stage and grade if it is not treated.\n\nComplex Physical Therapy (CPT), that includes Manual Lymph Drainage + Multilayer Bandage + Self-care, is the most used technique in order to join the benefits of each technique by the lack of great results with only one technique. The most volume reduction found in a study was achieved combining CPT and Pressotherapy(P). On the other hand, the use of Kinesio Taping (KT) for BCRL has been spreading lately although its clinical efficacy has not been determined by high quality studies.\n\nGOALS:\n\nMain objective: To analyze the effectiveness in the reduction of BCRL volume with KT versus CPT+P in patients attended at the rehabilitation service at HU12Octubre.\n\nSecondary objectives:\n\nTo analyze possible changes after each therapy in:\n\n* DASH (Disability Arm, Shoulder and Hand) outcome measure score.\n* TTDL (textile therapeutic device for lymphedema) questionnaire score (a quality of life questionnaire for patients with breast cancer-related upper lymb lymphedema using textile therapeutic device that has been validated previously).\n* Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using visual analogue scale (VAS).\n* Goniometry of Upper Limb.\n\nMETHODOLOGY OF THE STUDY:\n\nDesign: crossover trial, with a 3-month washout period between both treatment phases. Open design: it is impossible during the treatment to blind physiotherapists and patients, due to the observable differences between both therapies neither during their application nor in the hours after their removal, by the marks left in the skin. The statistical analysis will be supervised by staff of the Clinical Research Unit-Clinical Trials (i+12) of HU12Octubre with the variables coded to blind the analyst.\n\nInterventions: The two therapies compared are:\n\n* CPT+ P.\n* KT. Sample size: a sample of 50 patients (25 in each group) was calculated. Subjects of study and randomization: An initial computerized randomized sample was generated among the patients who had attended the Breast Pathology Rehabilitation visit at HU12Octubre during the previous year and who met the eligibility criteria and they were randomly assigned to the groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Submit BCRL\n2. Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre.\n3. Signing the informed consent.\n\nExclusion Criteria:\n\n1\\) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection (erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6) present deterioration or cognitive delay that would prevent understanding instructions and purpose of the study.\n\n7\\) Have performed treatment for BCRL during the 3 months prior to the start of the study (previous washing phase).'}, 'identificationModule': {'nctId': 'NCT03051750', 'briefTitle': 'Comparison of Techniques for Breast Cancer-Related Lymphedema.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial.', 'orgStudyIdInfo': {'id': 'InveCuidRh150316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPT+P', 'description': 'Complex Physical Therapy plus Pressotherapy during three weeks', 'interventionNames': ['Other: Complex Physical Therapy plus Pressotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping', 'description': 'Kinesio Taping during three weeks', 'interventionNames': ['Other: Kinesio Taping']}], 'interventions': [{'name': 'Complex Physical Therapy plus Pressotherapy', 'type': 'OTHER', 'armGroupLabels': ['CPT+P']}, {'name': 'Kinesio Taping', 'type': 'OTHER', 'armGroupLabels': ['Kinesio Taping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Violeta Pajero Otero, MRes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Violeta Pajero Otero', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist at the Mammary Pathology Unit', 'investigatorFullName': 'Violeta Pajero Otero', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}