Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01003951
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2009-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for the Treatment of Chronic Lymphedema
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-15', 'studyFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.', 'timeFrame': 'twice weekly for four consecutive weeks and will be followed for an additional 6 months'}], 'secondaryOutcomes': [{'measure': 'To further evaluate the safety of acupuncture in this setting.', 'timeFrame': '6 months to record any side effects that may occur post-treatment'}, {'measure': 'To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Lymphedema', 'Acupuncture', '09-136'], 'conditions': ['Breast Cancer', 'Lymphedema']}, 'referencesModule': {'references': [{'pmid': '23576267', 'type': 'DERIVED', 'citation': 'Cassileth BR, Van Zee KJ, Yeung KS, Coleton MI, Cohen S, Chan YH, Vickers AJ, Sjoberg DD, Hudis CA. Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study. Cancer. 2013 Jul 1;119(13):2455-61. doi: 10.1002/cncr.28093. Epub 2013 Apr 10.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most often in the arms and/or legs, and occasionally in other parts of the body. Lymphedema can occur when lymph vessels are damaged or lymph nodes are removed. Lymphedema can develop right after breast cancer treatment or weeks, months, or even years later. For many people, available treatments for lymphedema are not effective. Recent evidence suggests that acupuncture may help reduce the symptoms of lymphedema. The purpose of this study is to determine the effects of acupuncture on chronic lymphedema. This study will look further at whether acupuncture can reduce lymphedema and help us to understand immune changes that may be associated with improvements in lymphedema.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 18 or older willing to sign consent.\n* Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per Breast surgeon or medical oncologist.\n* Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years after diagnosis of chronic lymphedema.\n* The affected arm must be \\>2cm larger than the unaffected arm; this is the standard diagnosis and the one used in the MSKCC studies cited above. The standard measurement techniques will be applied 20.\n\nExclusion Criteria:\n\n* Previous acupuncture treatment for lymphedema\n* Diuretic use\n* History of primary (congenital) lymphedema\n* Metastatic cancer\n* History of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis)\n* History of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma\n* Current treatment with corticosteroids\n* Treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment\n* History of bone marrow transplantation'}, 'identificationModule': {'nctId': 'NCT01003951', 'briefTitle': 'Acupuncture for the Treatment of Chronic Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study', 'orgStudyIdInfo': {'id': '09-136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Each patient will receive two acupuncture treatments each week for four consecutive weeks. At the end of four weeks, the intervention will be complete.', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': "Acupuncture treatments will be given at the Integrative Medicine Outpatient Center, if needed in particular cases, at the MSKCC Breast Center. Each treatment is 30-40 minutes in duration. Each patient will receive two acupuncture treatments each week for four consecutive weeks.\n\nBefore and after each treatment, the circumference of the patient's upper arm, and forearm will be measured in both the affected and unaffected arms. The greater difference between affected and unaffected arms (either the forearm or the upper arm) for each patient will be used for outcome assessment. Photographs of the patient's affected and unaffected arms before and after each treatment will be taken to provide visual documentation of status. The patient's face will not appear in the photographs. Blood draws will be performed from the unaffected arm in serum collection tubes and will be performed within 1 week of starting acupuncture and within 1 week of completion of the 4 week protocol.", 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Barrie Cassileth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}