Acupuncture in Treating Lymphedema in Patients with Breast Cancer
Inclusion Criteria
- 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)
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
New York
New York
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
Lead Organization
Memorial Sloan Kettering Cancer Center
Principal Investigator
Ting Bao
- Primary ID 12-210
- Secondary IDs NCI-2012-02169
- Clinicaltrials.gov ID NCT01706081