Overview

This trial is active, not recruiting.

Condition breast cancer with chronic lymphedema
Treatments acupuncture, wait-list
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date October 2012
End date October 2017
Trial size 83 participants
Trial identifier NCT01706081, 12-210

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
acupuncture
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.
(Experimental)
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
wait-list
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.

Primary Outcomes

Measure
difference in the extent of lymphedema
time frame: 2 years
effectiveness
time frame: 2 years

Secondary Outcomes

Measure
differences between treatment group for bioimpedance
time frame: 2 years
safety
time frame: 1. 5 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
Principal investigator Ting Bao, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in November 2016.