Acupuncture for Chronic Lymphedema
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.
|Breast Cancer With Chronic Lymphedema||Procedure: Acupuncture Procedure: Wait-list||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial|
- difference in the extent of lymphedema [ Time Frame: 2 years ]The difference in the extent of lymphedema between groups will be assessed with an analysis of covariance (ANCOVA) model with extent of lymphedema after 6 weeks as the outcome with treatment group and baseline extent of lymphedema as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups.
- effectiveness [ Time Frame: 2 years ]of acupuncture for the treatment of breast cancer-related lymphedema (BCRL) as measured by arm circumference after 6 weeks of acupuncture treatment.
- differences between treatment group for bioimpedance [ Time Frame: 2 years ]ANCOVA models will be used to assess differences between treatment group for bioimpedance. The 6-week score will be the outcome and treatment group, baseline score, and randomization stratum will be included as covariates. We will report the two-tailed p-value and a 95% confidence interval for the difference between groups.
- safety [ Time Frame: 1. 5 years ]Severity will be graded as "serious" or "non-serious". Serious AEs are those that require hospitalization, lead to death or disability or require urgent medical attention to prevent death or disability. The intensity of non-serious AEs will be graded as mild, moderate or severe.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
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.
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706081
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ting Bao, MD||Memorial Sloan Kettering Cancer Center|