Acupuncture for Chronic Lymphedema
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/23/2017 |
| Start Date: | October 2012 |
| End Date: | October 2018 |
Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Ting Bao, MD
Phone: 646-888-0842
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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