Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00058851
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2003-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}, {'id': 'D058128', 'term': 'Compression Bandages'}], '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'}, {'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-17', 'studyFirstSubmitDate': '2003-04-14', 'studyFirstSubmitQcDate': '2003-04-14', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volume change'}]}, 'conditionsModule': {'keywords': ['Manual lymph drainage', 'Combined physiotherapy'], 'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.', 'detailedDescription': 'Massage therapy (in the form of manual lymph drainage \\[MLD\\]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.\n\nPatients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lymphedema (5% to 20% increase in volume) after breast cancer treatment\n\nExclusion Criteria:\n\n* Physically unable to perform massage or bandaging during home program'}, 'identificationModule': {'nctId': 'NCT00058851', 'briefTitle': 'Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Massage Therapy for Breast Cancer-Related Lymphedema', 'orgStudyIdInfo': {'id': 'R21AT001326-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001326-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Manual lymph drainage', 'type': 'PROCEDURE'}, {'name': 'Combined physiotherapy', 'type': 'PROCEDURE'}, {'name': 'Compression bandaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Michael J Bernas, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}