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Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Lymphedema

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Trial Information

Acupuncture for the Treatment of Chronic Lymphedema: A Feasibility Study


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To obtain preliminary evidence of the effects of acupuncture on chronic lymphedema due to breast cancer treatment.

Outcome Time Frame:

twice weekly for four consecutive weeks and will be followed for an additional 6 months

Safety Issue:

No

Principal Investigator

Barrie Cassileth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-136

NCT ID:

NCT01003951

Start Date:

October 2009

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Lymphedema
  • Lymphedema
  • Acupuncture
  • 09-136
  • Breast Neoplasms
  • Lymphedema

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021