Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severity of lymphedema - percentage of excess limb volume (PCEV, ml)
研究概览
简要总结
In this study, the purpose of this study is to investigate whether prophylactic medical compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could reduce the incidence and severity of lymphedema in the upper limbs that received axillary lymph node resection (sentinel lymph node biopsy or axillary lymph node dissection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who underwent radical mastectomy and sentinel lymphctomy or axillary lymphectomy after diagnosis of unilateral breast cancer
- •Patients who are scheduled for adjuvant chemotherapy including Docetaxel after surgery
- •Patients aged 19 to 70
- •Patients who can understand the contents of this study and obtain consent
排除标准
- •Patients with a history of breast-related surgery prior to this breast cancer surgery
- •Patients with metastases to other organs
- •Patients who have undergone neoadjuvant chemotherapy or have previously received radiation therapy
- •Patients with systemic diseases that may not be able to conduct clinical research
- •Patients with skin diseases who cannot receive medical compression treatment
结局指标
主要结局
Severity of lymphedema - percentage of excess limb volume (PCEV, ml)
时间窗: Time of occurrence of lymphedema during the follow-up period
Limb lymphedema volumes were measured using the electronic volumeter device (Perometer; Pero-System, Wuppertal, Germany), which is an optoelectronic instrument for measuring limb volume and circumferences. PCEV (%) = \[(volume of affected limb - volume of unaffected limb) / volume of unaffected limb\] × 100 Volume comparison between groups at the onset of lymphedema during the follow-up period (Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year)
The cumulative incidence rate of lymphedema (%)
时间窗: The cumulative incidence of lymphedema during the entire primary observation period
The cumulative incidence rate of lymphedema The cumulative incidence of lymphedema during the entire primary observation period (Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year) permanent lymphedema criteria: 1. excess limb volume (≥10%, forearm or whole arm) 2. excess limb volume (\<10%, forearm or whole arm, If there is regional lymphedema suitable for lymphatic territory and a Lymphedema specialist makes a clinical diagnosis)
次要结局
- ECW/TBW ratio (%) of whole body (body water analysis result)(Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year)
研究者
JiHye Hwang
Professor
Samsung Medical Center