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Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial

Phase 2
18 Years
Open (Enrolling)
Breast Cancer With Chronic Lymphedema

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Trial Information

Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial

Inclusion Criteria:

- Women age 18 or older

- 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. This timeframe allows ample time for any surgically related
non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years
will capture the broadest range of cases, and has been used as a timeframe in several
studies including our pilot study.

- The affected arm must be >2cm larger than the unaffected arm. Differences of 2 cm or
more between the affected and unaffected arm are considered by experts to be
clinically significant. Each affected arm will be measured in two areas: upper arm
and forearm.

The larger of the two measures—upper arm or forearm— will be used for analysis.

- Classified as International Society of Lymphology (ISL) stage II or higher as
determined by an MSKCC Certified Lymphedema Therapist (CLT).

Exclusion Criteria:

- Bilateral lymphedema

- Previous acupuncture treatment for lymphedema

- Concurrent diuretic use

- History of primary (congenital) lymphedema

- Pregnant or planning to become pregnant during the course of the study

- Has an implanted electronically charged medical device

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

difference in the extent of lymphedema

Outcome Description:

The difference in the extent of lymphedema between groups will be assessed with an analysis of covariance (ANCOVA) model with extent of lymphedema after 6 weeks as the outcome with treatment group and baseline extent of lymphedema as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Barrie Cassileth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer With Chronic Lymphedema
  • acupuncture
  • Breast Neoplasms
  • Lymphedema



Memorial Sloan Kettering Cancer Center New York, New York  10021