Clinical trial NCT01003951: Acupuncture for the Treatment of Chronic Lymphedema
Official title: Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lymphedema
Keywords: Lymphedema
Acupuncture
09-136
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.
timeFrame: twice weekly for four consecutive weeks and will be followed for an additional 6 months
Secondary outcomes:
measure: To further evaluate the safety of acupuncture in this setting.
timeFrame: 6 months to record any side effects that may occur post-treatment
measure: To obtain preliminary evidence of systemic immune changes that occur after acupuncture treatment of lymphedema.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Barrie Cassileth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassileth BR, Van Zee KJ, Yeung KS, Coleton MI, Cohen S, Chan YH, Vickers AJ, Sjoberg DD, Hudis CA. Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study. Cancer. 2013 Jul 1;119(13):2455-61. doi: 10.1002/cncr.28093. Epub 2013 Apr 10.