Effectiveness of Acupuncture for Breast Cancer Related Lymphedema
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Absolute Reduced Limb Volume Ratio
研究概览
简要总结
This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in two groups: the real acupuncture group and the sham acupuncture group.
详细描述
In the theory of Traditional Chinese Medicine (TCM), Breast Cancer Related Lymphedema (BCRL) is classified as "edema", and is considered to be caused by qi (chi) deficiency and blood stagnation. Acupuncture, as an ancient therapy in TCM, is thought to have the efficacy to stimulate the transformation of qi and drainage of dampness, and is widely used for various diseases including edema in China. Early clinical trials as well as our own clinical observation have demonstrated that acupuncture can ameliorate limb swelling and decrease lymphedema. However, no randomized placebo-controlled trial has been performed to evaluate this efficacy of acupuncture. Therefore, this study aimed to evaluate the safety and potential efficacy of acupuncture to treat chronic upper-limb lymphedema.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who completed all primary and adjuvant treatments.
- •age between 20 and
- •BMI between 18 and
- •unilateral lymphedema resulting from surgery for breast cancer.
- •mild to moderate lymphedema, with 10% to 40% increase in volume compared to the unaffected arm based on perometry evaluation.
- •with no evidence of recurrence.
排除标准
- •bilateral lymphedema.
- •history of bilateral axillary lymph node dissection.
- •serious lymphedema, with over 40% increase in volume compared to the unaffected arm based on perometry evaluation.
- •pregnant women.
- •unable to adhere to the protocol or the treatment schedule.
- •recurrent breast cancer or other malignancies.
- •current use of chemotherapy or radiation.
- •current use of diuretic drugs like Diosmin, or other investigational drugs.
结局指标
主要结局
Absolute Reduced Limb Volume Ratio
时间窗: Day 0 (baseline), Day 30(endpoint)
Data of the absolute limb volume will be collected before the treatment (volume at baseline, B) and after the treatment (volume after therapy, A) for every participant. VL is the volume of the affected arm with lymphedema, and VC is the volume of the contralateral arm. Then, The ARLVR will be calculated using the following formula: ARLVR (%) = (VL-Vc)B-( VL-Vc)A/( VL-Vc)B ×100%. The arm measurement will be conducted using perometer. This method is inspired by the method established by Anderson et al.
次要结局
- Incidence of Adverse Event(Day 0 (baseline), Day 30(endpoint))