Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change of excess limb volume (ELV)
研究概览
简要总结
The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.
详细描述
Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.
Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.
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 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
- •Participants must be ≥ 2 months after chemo- and radiotherapy
- •Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
- •Participants must be motivated for treatment with compression sleeve and -gauntlet
- •Participants live in and around Aarhus, Denmark
排除标准
- •Known metastatic disease
- •Contraindication for treatment with compression sleeve
- •Upper extremity deep venous thrombosis
- •Previously use of compression sleeve
- •Known contact allergy to latex
- •Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
结局指标
主要结局
Change of excess limb volume (ELV)
时间窗: 8 weeks follow-up
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
次要结局
- Changes in arm disability(8 weeks follow-up)
- Changes in subjective symptoms (pain, tension, and heaviness)(8 weeks follow-up)
研究者
Mette Brodersen Jerver
Physiotherapist
Aarhus University Hospital