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 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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study|
- 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 ] [ Designated as safety issue: No ]
- To further evaluate the safety of acupuncture in this setting. [ Time Frame: 6 months to record any side effects that may occur post-treatment ] [ Designated as safety issue: Yes ]
- To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Each patient will receive two acupuncture treatments each week for four consecutive weeks. At the end of four weeks, the intervention will be complete.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003951
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Barrie Cassileth, MD||Memorial Sloan-Kettering Cancer Center|