Acupuncture for Chronic Lymphedema
Condition: Breast Cancer With Chronic Lymphedema
MeSH terms: Lymphedema
Intervention: Acupuncture; Wait-list
Intervention description: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.; For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acupuncture

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