Acupuncture for the Treatment of Chronic Lymphedema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01003951|
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lymphedema||Procedure: Acupuncture||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
- To further evaluate the safety of acupuncture in this setting. [ 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 ]
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
|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|