Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Lymphedema as Measured at Baseline and at 6 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Acupuncture
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
干预措施: Acupuncture (Procedure)
Wait-list
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
干预措施: Wait-list (Procedure)
结局指标
主要结局
Lymphedema as Measured at Baseline and at 6 Weeks
时间窗: 6 weeks
Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.
次要结局
- Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks(6 weeks)
- Number of Participants Evaluated for Adverse Events(1. 5 years)