Acupuncture in Treating Lymphedema in Patients with Breast Cancer

Status: Complete

Description

This randomized clinical trial studies how well acupuncture works in treating lymphedema in patients with breast cancer. Acupuncture may help treat lymphedema caused by surgery, chemotherapy, and / or radiation therapy for breast cancer.

Eligibility Criteria

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

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

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 & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Ting Bao

Trial IDs

Primary ID 12-210
Secondary IDs NCI-2012-02169
Clinicaltrials.gov ID NCT01706081