Clinical trial NCT01706081: Acupuncture for Chronic Lymphedema
Official title: Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer With Chronic Lymphedema
Keywords: acupuncture
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph system fluid that causes swelling in the arm. The swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. It can develop right after breast cancer treatment or weeks, months or even years later. In our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup.

This study will include a larger group of patients. Patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.


Eligibility criteria: 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

Primary outcomes:
measure: Lymphedema as Measured at Baseline and at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks
timeFrame: 6 weeks
measure: Number of Participants Evaluated for Adverse Events
timeFrame: 1. 5 years
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: Ting Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: