Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- The percentage volume reduction of lymphoedema (%)
研究概览
简要总结
The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.
详细描述
Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.
A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The diagnose breast cancer regardless of date for operation and identified lymphoedema
- •Precede ultrasonic scanning of axilla in order to exclude local relapse
- •Lymphoedema > 2 cm i.e. stage II-III
- •Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion
排除标准
- •Relapse of breast cancer
- •Untreated infection
- •Untreated heart failure
- •Untreated renal failure
- •Untreated deep venous thrombosis in the arm
- •Unable to participate in physiotherapy treatment and/or not able to understand instructions
结局指标
主要结局
The percentage volume reduction of lymphoedema (%)
时间窗: 7 months
次要结局
- Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life(7 months)
研究者
Valgerdur Hilmarsdottir Gram
Associate Professor, PhD
Esbjerg Hospital - University Hospital of Southern Denmark