Comparison of Effectiveness Between Warm Acupuncture With Local-Distal Points Association and Local Distribution Points Association in Breast Cancer Related Lymphedema Patients: A Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Upper extremity circumference
研究概览
简要总结
The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related 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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms.
- •Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
- •Karnofsky Performance Score (KPS) ≥ 70
- •Men or women aged 18 to 80 years
- •Out-patients
- •Estimated life expectancy > 6 months
排除标准
- •Bilateral breast cancer related lymphedema
- •Taking diuretic
- •History of primary lymphedema
- •A diagnosis of severe heart, liver, kidney or hematologic disease
- •Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
- •Have hypoproteinemia
- •Inflammation, scar, or trauma at the site of operation, or other active skin infections
- •Unable to self-care, had a history of psychological disorders, or unable to communicate
- •Received lymphedema treatment within the past 1 month
- •Pregnancy or breastfeeding
- •The presence of electronic medical device implants
- •Deny to sign the informed written consent, or unwilling to conform to randomization
- •Participation in other clinical trials during the study period
研究组 & 干预措施
local distribution points association
Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
干预措施: local distribution points association (Other)
local-distal points association
Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
干预措施: local-distal points association (Other)
waiting-list
Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed.
结局指标
主要结局
Upper extremity circumference
时间窗: 80 weeks
Various assessment methods are available but circumference measure is simple, convenient with low cost, and reliable. Therefore, the primary outcome measures will be the mean change in inter-limb circumference difference from baseline to the end of the 8-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease, 10 cm above the wrist crease, elbow crease, 10 cm above the elbow crease, where the lymphedema is most severe and its corresponding location on the unaffected limb.
次要结局
- Upper extremity volume(80 weeks)
- Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria(80 weeks)
- Stages of lymphedema from the international society of lymphology(80 weeks)
- The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure(80 weeks)
- The MOS 36-Item Short-Form Health Survey (SF-36)(80 weeks)
研究者
Yi Guo
The Dean of Acupuncture and Moxibustion College
Tianjin University of Traditional Chinese Medicine