Acupuncture in Treating Lymphedema in Patients with Breast Cancer
- 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 > 2 cm 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 a Memorial Sloan-Kettering Cancer Center (MSKCC) certified lymphedema therapist (CLT)
- 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
I. To determine the effectiveness of acupuncture for the treatment of breast cancer-related lymphedema (BCRL) as measured by arm circumference after 6 weeks of acupuncture treatment.
I. To assess differences between treatment groups in bioimpedance scores.
II. To determine the safety of acupuncture treatment for BCRL.
III. To determine whether changes in lymphedema resulting from 6 weeks of acupuncture treatment are sustained over a 3-month follow-up period.
IV. To determine whether time since lymphedema diagnosis affects response to acupuncture.
V. To determine whether stage affects response to acupuncture.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (acupuncture): Patients undergo acupuncture therapy over 30 minutes twice weekly for 6 weeks.
ARM II (wait list control): Patients receive no treatment for 6 weeks. After 6 weeks, patients cross over to Arm I.
After completion of study treatment, patients are followed up within 1 week and then at 3 months.
Trial Phase Phase NA
Trial Type Supportive care
Memorial Sloan Kettering Cancer Center
- Primary ID 12-210
- Secondary IDs NCI-2012-02169
- Clinicaltrials.gov ID NCT01706081