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Acupuncture for the Treatment of Chronic Lymphedema

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ClinicalTrials.gov Identifier: NCT01003951
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Procedure: Acupuncture Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study
Study Start Date : October 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
Each patient will receive two acupuncture treatments each week for four consecutive weeks. At the end of four weeks, the intervention will be complete.
 Procedure: Acupuncture

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.

Before 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.


Outcome Measures
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Primary Outcome Measures :
  1. To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment. [ Time Frame: twice weekly for four consecutive weeks and will be followed for an additional 6 months ]

Secondary Outcome Measures :
  1. To further evaluate the safety of acupuncture in this setting. [ Time Frame: 6 months to record any side effects that may occur post-treatment ]
  2. To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema. [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women age 18 or older willing to sign consent.
  • Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per Breast surgeon or medical oncologist.
  • 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.
  • 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.

Exclusion Criteria:

  • Previous acupuncture treatment for lymphedema
  • Diuretic use
  • History of primary (congenital) lymphedema
  • Metastatic cancer
  • History of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis)
  • History of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma
  • Current treatment with corticosteroids
  • Treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment
  • History of bone marrow transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003951


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Barrie Cassileth, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01003951    
Other Study ID Numbers: 09-136
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012
Keywords provided by Memorial Sloan Kettering Cancer Center:
Lymphedema
Acupuncture
09-136
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases