The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
研究概览
简要总结
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.
Study Design:Randomized, Pilot Study
详细描述
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •are female
- •have operable, early stage breast cancer stage 0 - IIIA
- •undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
- •are aged > 18 years of age at the date of enrollment
- •are willing to sign an informed consent form
排除标准
- •have had a bilateral axillary surgery
- •do not undergo axillary evaluation
- •are a minor
- •cannot consider the issues involved in making an informed and autonomous decision.
研究组 & 干预措施
Observation
Observation arm will continue to be followed with serial L-Dex and water volume displacement methods.
干预措施: Garment Sleeve (Device)
Intervention-garment sleeve
If the L-Dex is outside the normal range, or has increased 10 units from baseline, the patient will then be randomized to wear a compression sleeve (20 to 30 mm of Hg) daily for 4 weeks or observation (no sleeve). After 4 weeks, L-Dex measurements and water volume displacement will be reassessed in the treatment group.
干预措施: Garment Sleeve (Device)
结局指标
主要结局
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
时间窗: 2 years
Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.
次要结局
- 200 women will have bioimpedance and volume displacement measurements to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema as compared to standard (volume displacement)(2 years)