Does a Regime of Manual Lymphatic Drainage Reduce the Incidence of Breast Cancer-related Lymphoedema Following Axillary Node Clearance: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Absolute difference in arm volumes
研究概览
简要总结
Axillary lymph nodes are the main site of metastasis in breast cancer. If positive axillary lymph nodes are present, an axillary lymph node dissection (ALND) is usually performed. This procedure improves disease-free survival but comes with the risk of lymphoedema as a result of disrupted lymphatic channels. Breast cancer-related lymphoedema (BCRL) is associated with considerable morbidity, which is why proven measures to reduce its incidence would improve patient outcomes. We aimed to investigate whether a regime of manual lymphatic drainage and exercise, supervised by a manual lymphatic drainage therapist compared to standard care would reduce the incidence of breast cancer-related lymphoedema in patients undergoing ALND.
详细描述
Eligible patients were those in whom a primary operable breast cancer is diagnosed and in whom surgery is planned to include ALND. Patients with recurrent carcinoma, previous axillary surgery/radiotherapy or any previous arm/axillary pathology leading to arm volume changes will be excluded. Eligible participants will be identified at the breast multidisciplinary meeting and will be informed of the study and given a written information sheet. Patients who choose to participate will be asked to fill in a written consent form. Patients allocated to the decongestive lymphatic therapy group will undergo intervention for a total period of 3 months. This will consist of 2 visits to a qualified practitioner in Dr Vodder manual lymphatic drainage therapist, one at the start of the 3-month period and again 6 weeks later. Patients in both groups will also be instructed to perform self-MLD on a daily basis and will be taught a series of exercises to be performed on a daily basis. Compression hosiery will be fitted to be worn during the exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 120 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Absolute difference in arm volumes
时间窗: Through study duration, approximately 36 months
The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.
次要结局
- Patients adherence to the protocol stated exercises for 3 months post surgery(Through study duration, approximately 36 months)
