NCT04158193Unknown不适用
Effectiveness of Acupuncture for Breast Cancer Related Lymphedema Patients: a Multicenter, Randomized, Sham-controlled Clinical Trial
Tianjin University of Traditional Chinese Medicine0 个研究点目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Upper extremities volume
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery
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
- Female
- 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.
- •Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
- •Women aged 18 to 80 years
- •Out-patients
- •Estimated life expectancy > 6 months
- •Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms
排除标准
- •Bilateral breast cancer related lymphedema
- •Tumor metastasis or recurrent patient
- •Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
- •Taking diuretic
- •Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
- •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
结局指标
主要结局
Upper extremities volume
时间窗: 7 weeks
Volume measurement is also commonly used for the evaluation of lymphedema and the mean change in inter-limb volume difference from baseline to the end of the 7-week intervention will be included as primary outcome measure. The volume of the affected and unaffected limb will be measured by the volumetric measuring device (Baseline, America) using the water displacement method, which is considered as the most reliable method for volume measurements.
次要结局
- Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria(7 weeks)
- VAS distension score(7 weeks)
- The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure(7 weeks)
- Upper extremities circumferences(7 weeks)
- The MOS 36-Item Short-Form Health Survey (SF-36)(7 weeks)
研究者
Yi Guo
The Dean of Traditional Chinese medicine College
Tianjin University of Traditional Chinese Medicine
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