Acupuncture for the Treatment of Chronic Lymphedema
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...
Brief Summary
Official Title: “Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2012
Intervention(s) in this Clinical Trial
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: twice weekly for four consecutive weeks and will be followed for an additional 6 months
Secondary Measures
- To further evaluate the safety of acupuncture in this setting.
- Time Frame: 6 months to record any side effects that may occur post-treatment
Safety Issue?: Yes
- Time Frame: 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.
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Memorial Sloan-Kettering Cancer Center Other
Overall Clinical Trial Officials and Contacts
Barrie Cassileth, MD Principal Investigator Memorial Sloan-Kettering Cancer Center
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01003951
Study ID Number: 09-136
ClinicalTrials.gov Identifier: NCT01003951
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01003951
