Acupuncture for the Treatment of Chronic Lymphedema

Phase 2

Completed

• Conditions: Breast Cancer; Lymphedema
• Interventions: Procedure: Acupuncture

• Registration Number: NCT01003951
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.	twice weekly for four consecutive weeks and will be followed for an additional 6 months

Secondary Outcome Measures

Name	Time	Method
To further evaluate the safety of acupuncture in this setting.	6 months to record any side effects that may occur post-treatment
To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.	6 months

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States