Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Circumference measurements
研究概览
简要总结
OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.
DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.
SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.
DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of breast cancer.
- •Undergoing unilateral surgery with axillary lymph-node dissection.
排除标准
- •Bilateral breast cancer.
- •Systemic disease.
- •Locoregional recurrence.
- •Any contraindication to physical therapy.
研究组 & 干预措施
Early Manual Lymph Drainage
14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
干预措施: 14 sessions of manual lymphatic drainage technique (Procedure)
Early Manual Lymph Drainage
14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
干预措施: the health education (Other)
Health education for lymphedema prevention
Only the health education for lymphedema prevention.
干预措施: the health education (Other)
结局指标
主要结局
Circumference measurements
时间窗: 60 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.
Circumference measurements
时间窗: 0 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
Circumference measurements
时间窗: 3 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 3 months after surgery.
Circumference measurements
时间窗: 6 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 6 months after surgery.
Circumference measurements
时间窗: 12 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 12 months after surgery.
Circumference measurements
时间窗: 24 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 24 months after surgery.
Circumference measurements
时间窗: 36 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 36 months after surgery.
Circumference measurements
时间窗: 48 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 48 months after surgery.
次要结局
未报告次要终点