Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT04112966
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2019-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lymphedema Prevention 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circumference measurements', 'timeFrame': '0 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.'}, {'measure': 'Circumference measurements', 'timeFrame': '3 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 3 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '6 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 6 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '12 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 12 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '24 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 24 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '36 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 36 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '48 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 48 months after surgery.'}, {'measure': 'Circumference measurements', 'timeFrame': '60 months', 'description': 'Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphedema', 'Prevention'], 'conditions': ['Breast Cancer', 'Lymphedema']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.\n\nDESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.\n\nSUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.\n\nSAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.\n\nDATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of breast cancer.\n* Undergoing unilateral surgery with axillary lymph-node dissection.\n\nExclusion Criteria:\n\n* Bilateral breast cancer.\n* Systemic disease.\n* Locoregional recurrence.\n* Any contraindication to physical therapy.'}, 'identificationModule': {'nctId': 'NCT04112966', 'briefTitle': 'Lymphedema Prevention in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer', 'orgStudyIdInfo': {'id': 'ECA-DLM-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Manual Lymph Drainage', 'description': '14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.', 'interventionNames': ['Procedure: 14 sessions of manual lymphatic drainage technique', 'Other: the health education']}, {'type': 'OTHER', 'label': 'Health education for lymphedema prevention', 'description': 'Only the health education for lymphedema prevention.', 'interventionNames': ['Other: the health education']}], 'interventions': [{'name': '14 sessions of manual lymphatic drainage technique', 'type': 'PROCEDURE', 'description': 'Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.', 'armGroupLabels': ['Early Manual Lymph Drainage']}, {'name': 'the health education', 'type': 'OTHER', 'description': 'The health education for lymphedema prevention.', 'armGroupLabels': ['Early Manual Lymph Drainage', 'Health education for lymphedema prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45006', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Provincial Hospital', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Helena Romay Barrero, Prof. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Castilla-La Mancha'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'collaborators': [{'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}