Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- Measure of arms volume
研究概览
简要总结
ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.
Methods: Clinical randomized trial in two parallel groups over a two-year period.
Key words: lymphedema, breast cancer, prevention, rehabilitation
详细描述
This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:
- Patients between 18 and 85 years
- Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- Acceptance of the study conditions and signing of the informed consent
Exclusion criteria were:
- tumour recurrences
- metastatic cancer
- open wounds or loss of skin integrity
- dependency or deterioration of higher functions
- arterial insufficiency and deep vein thrombosis
- acute heart failure
- severe peripheral neuropathy
- lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.
The program common to both groups consisted of:
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
- •Acceptance of the study conditions and signing of the informed consent
排除标准
- •Tumour recurrences
- •Metastatic cancer
- •Open wounds or loss of skin integrity
- •Dependency or deterioration of higher functions
- •Arterial insufficiency and deep vein thrombosis
- •Acute heart failure
- •Severe peripheral neuropathy
- •Lymphedema
研究组 & 干预措施
Group EC1: Exercices, informative talk
Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program
干预措施: Exercices (Behavioral)
Group EC1: Exercices, informative talk
Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program
干预措施: Informative talk (Behavioral)
Group ECCP2: Exercices, informative talk, compression garment
Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment
干预措施: Exercices (Behavioral)
Group ECCP2: Exercices, informative talk, compression garment
Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment
干预措施: Informative talk (Behavioral)
Group ECCP2: Exercices, informative talk, compression garment
Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment
干预措施: Compression garment (Device)
结局指标
主要结局
Measure of arms volume
时间窗: All patients were evaluated at 3 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
Measure of arms volume
时间窗: All patients were evaluated at the start of the study
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
次要结局
未报告次要终点