Acupuncture for the Treatment of Chronic Lymphedema

Breast Cancer Clinical Trial

Official title:

Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003951
• Other study ID #: 09-136
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2009
• Last updated: August 15, 2012
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To further evaluate the safety of acupuncture in this setting.		6 months to record any side effects that may occur post-treatment	Yes
Secondary	To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.		6 months	No

External Links

•   Memorial Sloan-Kettering Cancer Center